AliveCor Heart Monitor
Transmitters And Receivers, Electrocardiograph, Telephone
ALIVECOR, INC.
The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Alivecor Heart Monitor.
Pre-market Notification Details
| Device ID | K142672 |
| 510k Number | K142672 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-19 |
| Decision Date | 2014-12-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B210AC0090 | K142672 | 000 |
Trademark Results [AliveCor Heart Monitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALIVECOR HEART MONITOR 86429113 4759571 Live/Registered |
AliveCor, Inc. 2014-10-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.