The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Alivecor Heart Monitor.
| Device ID | K140933 |
| 510k Number | K140933 |
| Device Name: | ALIVECOR HEART MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | ALIVECOR, INC. 30 MAIDEN LANE, 6TH FLOOR San Francisco, CA 94108 |
| Contact | Albert Boniske |
| Correspondent | Albert Boniske ALIVECOR, INC. 30 MAIDEN LANE, 6TH FLOOR San Francisco, CA 94108 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-11 |
| Decision Date | 2014-08-15 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALIVECOR HEART MONITOR 86429113 4759571 Live/Registered |
AliveCor, Inc. 2014-10-20 |