Identifiers
- 510(k) Number
- K181658 FDA 510(k)
- FDA Product Code
- DSI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MobileECG 2 BT is a Detector and Alarm, Arrhythmia device, designed to monitor and detect cardiac arrhythmias. It records and analyzes electrocardiogram (ECG) signals to identify irregular heart rhythms, including ST-segment deviations, and triggers alarms when abnormalities are detected.
This device is intended for use in clinical and ambulatory settings, supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K181658) and adheres to 21 CFR 870.1025 regulations. The MobileECG 2 BT is classified as Class II and falls under the Product Code DSI, ensuring compliance with established safety and performance standards for arrhythmia detection.
Frequently asked questions
What clinical settings is the MobileECG 2 BT intended for use in, and how does it function in those environments?
The MobileECG 2 BT is designed for use in both clinical and ambulatory settings, meaning it can be utilized in hospitals, doctor’s offices, or even for patient monitoring outside of traditional healthcare facilities. It functions by recording and analyzing electrocardiogram (ECG) signals to detect cardiac arrhythmias, including irregularities like ST-segment deviations. When abnormalities are identified, the device triggers alarms to alert clinicians, ensuring timely intervention.
Is the MobileECG 2 BT a single-use or reusable device, and what does this mean for maintenance and cleaning?
The MobileECG 2 BT is a reusable medical instrument, which means it is designed for repeated use after proper cleaning, disinfection, and maintenance. This allows healthcare facilities to maintain a consistent supply without frequent replacements, though it requires adherence to manufacturer guidelines for reprocessing to ensure safety and performance.
How do I determine the correct model or size for my facility’s needs, given the multiple registration numbers listed?
The registration numbers provided (e.g., 3012552532, 3007208829) are administrative identifiers used by regulatory bodies and do not indicate different models or sizes of the device. The MobileECG 2 BT is a single device type, and all variations are likely part of the same product line or batch tracking. For specific sizing or configuration needs, consult the manufacturer’s documentation or sales team to ensure compatibility with your facility’s workflow.
What regulatory pathway was followed for the FDA clearance of the MobileECG 2 BT, and what does this mean for compliance?
The MobileECG 2 BT received FDA clearance through a 510(k) premarket notification process, specifically under the Traditional pathway with a Substantially Equivalent (SESE) determination. This means the device was evaluated by the FDA’s Cardiovascular (CV) advisory committee and deemed comparable to a legally marketed predicate device in terms of safety and effectiveness. Facilities using this device must ensure compliance with 21 CFR 870.1025 and other relevant regulations to maintain proper operational standards.
How should the MobileECG 2 BT be stored to maintain its performance and longevity?
Since the MobileECG 2 BT is a reusable device, proper storage is critical to preserve its functionality. It should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, and sources of electromagnetic interference. Follow the manufacturer’s instructions for storage conditions, including any specific packaging or protective measures, to ensure the device remains operational for repeated use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MobileECG 2 BT (K181658) — FDA 510(k) | Innolitics, Memtec Corporation, 510 (k) K181658 — MobileECG 2 BT — RegDataLab, Memtec Corp FDA Filings
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181658 | Class II | Active |
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Manufacturer
- Manufacturer
- Memtec Corporation
Sources (1)
- FDA 510(k) K181658 24 fields · synced Sep 20, 2026