MobileECG System
FDA 510(k)Class II (US FDA 510(k))
by Memtec Corp.
Identifiers
- 510(k) Number
- K103427 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MobileECG System is a True 12-Lead PC based ECG/EKG machine that wirelessly streams ECG data from the patient to a personal computer. It is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether in a hospital or primary care setting, and is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction.
The device is supplied as a system for use with a personal computer, requiring patient hookup, input of patient data into the software, and initiation of analysis. It is authorized under FDA 510(k) clearance (K103427) and manufactured by Memtec Corp. in Salem, NH. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the data.
Frequently asked questions
What is the MobileECG System used for?
The MobileECG System is intended to provide an interpretation of the resting 12-lead ECG in all situations, whether in a hospital or primary care setting, and is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction.
How is the MobileECG System supplied and what does it require for use?
The device is supplied as a system for use with a personal computer, requiring patient hookup, input of patient data into the software, and initiation of analysis to function properly.
Is the MobileECG System sterile or single-use?
No information regarding sterility, single-use or reusable status is provided in the device data, so these details cannot be confirmed from the available specifications.
What regulatory pathway was used for the MobileECG System?
The MobileECG System is authorized under FDA 510(k) clearance with K-number K103427, indicating it was found substantially equivalent to a predicate device through a traditional review process.
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: Memtec Corporation, Memtec Corporation, MOBILEECG SYSTEM by MEMTEC CORP. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103427 | Class II | Active |
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Manufacturer
- Manufacturer
- Memtec Corp.
Sources (1)
- FDA 510(k) K103427 24 fields · synced Sep 24, 2026