The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Alivecor Heart Monitor Otc.
| Device ID | K130921 |
| 510k Number | K130921 |
| Device Name: | ALIVECOR HEART MONITOR OTC |
| Classification | Electrocardiograph |
| Applicant | ALIVECOR, INC. 30 MAIDEN LANE, 6TH FLOOR San Francisco, CA 94108 |
| Contact | Michael Righter |
| Correspondent | Michael Righter ALIVECOR, INC. 30 MAIDEN LANE, 6TH FLOOR San Francisco, CA 94108 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-03 |
| Decision Date | 2014-02-06 |