510(k) K181310
K181310 is an FDA 510(k) premarket notification submitted by Cardiocomm Solutions, Inc. for the device "HeartCheck Cardi Beat ECG Monitor with GEMS Mobile". The FDA issued a decision of Substantially Equivalent on Feb 22, 2019. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Cardiocomm Solutions, Inc. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 2019
- Date Received
- May 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type
- 510(k)