{
  "format": "devicerts.device.v1",
  "cite_as": "Mediblu ECG System, Mediblu Medical, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/mediblu-ecg-system-dps (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/mediblu-ecg-system-dps",
    "json_url": "https://devicerts.com/devices/mediblu-ecg-system-dps.json",
    "markdown_url": "https://devicerts.com/devices/mediblu-ecg-system-dps.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/mediblu-ecg-system-dps",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Mediblu ECG System",
    "registry_name": "MEDIBLU ECG SYSTEM",
    "url": "https://devicerts.com/devices/mediblu-ecg-system-dps",
    "manufacturer": {
      "name": "Mediblu Medical, LLC",
      "url": "https://devicerts.com/manufacturers/mediblu-medical-llc",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K233266",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "DPS"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Mediblu ECG System is a diagnostic electrocardiograph classified under the FDA’s product code DPS. It is designed to acquire, display, and record electrocardiogram (ECG) signals from adult and pediatric patients using body surface electrodes. The device amplifies and processes electrical signals from the heart to generate a graphical representation of cardiac activity for clinical assessment. Its primary function aligns with standard ECG monitoring devices, enabling real-time cardiac rhythm evaluation and diagnostic interpretation.\n\nThe Mediblu ECG System is supplied as a reusable medical device intended for use in clinical settings such as hospitals, emergency rooms, and cardiology clinics. It operates under standard electrical safety standards and is not classified as MRI-safe or MRI-conditional. The system includes multiple models (ME3, ME6P, ME12P, ME15P) tailored for varying patient monitoring needs. Cleared via FDA’s 510(k) pathway (K233266) under the Traditional review process, it adheres to regulatory requirements for Class 2 Cardiovascular devices. Storage and maintenance instructions are manufacturer-specific and must be followed to ensure device integrity and performance.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K233266",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-06-12",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K233266",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "DPS",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 870.2340",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Cardiovascular",
              "registries": [
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            }
          ]
        },
        {
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          "values": [
            {
              "value": "SESE",
              "registries": [
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              ]
            }
          ]
        }
      ]
    }
  ]
}