HeartCheck Cardi Beat ECG Monitor with GEMS Mobile— 510(k) K181310
Substantially EquivalentCardiocomm Solutions, Inc.
FDA 510(k) clearance K181310 for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile, Substantially Equivalent on 2019-02-22. Applicant: Cardiocomm Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiocomm Solutions, Inc.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North York, CA
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