The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Alivecor Heart Monitor.
Device ID | K130409 |
510k Number | K130409 |
Device Name: | ALIVECOR HEART MONITOR |
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 | 2013-02-19 |
Decision Date | 2013-09-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ALIVECOR HEART MONITOR 86429113 4759571 Live/Registered |
AliveCor, Inc. 2014-10-20 |