The following data is part of a premarket notification filed by Cardiocomm Solutions, Inc. with the FDA for Heartcheck Cardi Beat Ecg Monitor With Gems Mobile.
| Device ID | K181310 |
| 510k Number | K181310 |
| Device Name: | HeartCheck Cardi Beat ECG Monitor With GEMS Mobile |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | CardioComm Solutions, Inc. 259 Yorkland Road, Suite 200 North York, CA L0a 1j0 |
| Contact | Jill Turcotte |
| Correspondent | Jill Turcotte CardioComm Solutions, Inc. 259 Yorkland Road, Suite 200 North York, CA L0a 1j0 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-17 |
| Decision Date | 2019-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812324000044 | K181310 | 000 |