{
  "format": "devicerts.device.v1",
  "cite_as": "Argus, Model LCM, Schiller AG. deviCERTS medical device catalogue. https://devicerts.com/devices/argus-model-lcm-mhx (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/argus-model-lcm-mhx",
    "json_url": "https://devicerts.com/devices/argus-model-lcm-mhx.json",
    "markdown_url": "https://devicerts.com/devices/argus-model-lcm-mhx.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": "2026-11-14",
    "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/argus-model-lcm-mhx",
    "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": "Argus, Model LCM",
    "registry_name": "ARGUS, MODEL LCM",
    "url": "https://devicerts.com/devices/argus-model-lcm-mhx",
    "manufacturer": {
      "name": "Schiller AG",
      "url": "https://devicerts.com/manufacturers/schiller-ag",
      "country": "Switzerland",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K053207",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "MHX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Argus, Model LCM is a physiological patient monitor with arrhythmia detection or alarms, classified as a Class II medical device. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA. The device is intended for cardiovascular monitoring applications.\n\nIt is manufactured by Schiller AG and supplied as a reusable patient monitor. The device requires connection to power and patient sensors for operation, and is used in clinical settings for continuous physiological monitoring. Storage and handling should follow the manufacturer's instructions provided in the operating and service manuals.",
      "ai_generated": true,
      "generated_on": "2026-10-06",
      "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": "K053207",
      "number_label": null,
      "device_udi_di": null,
      "date": "2006-05-19",
      "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": "K053207",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "MHX",
              "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 870.1025",
              "registries": [
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            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Cardiovascular",
              "registries": [
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            }
          ]
        },
        {
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          "values": [
            {
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            }
          ]
        }
      ]
    }
  ]
}