The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Alivecor Heart Monitor.
Device ID | K142743 |
510k Number | K142743 |
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 | 2014-09-24 |
Decision Date | 2015-01-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ALIVECOR HEART MONITOR 86429113 4759571 Live/Registered |
AliveCor, Inc. 2014-10-20 |