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 IDK142672
510k NumberK142672
Device Name:AliveCor Heart Monitor
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant ALIVECOR, INC. 30 MAIDEN LANE, 6TH FLOOR San Francisco,  CA  94108
ContactAlbert Boniske
CorrespondentAlbert Boniske
ALIVECOR, INC. 30 MAIDEN LANE, 6TH FLOOR San Francisco,  CA  94108
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-19
Decision Date2014-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B210AC0090 K142672 000

Trademark Results [AliveCor Heart Monitor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ALIVECOR HEART MONITOR
ALIVECOR HEART MONITOR
86429113 4759571 Live/Registered
AliveCor, Inc.
2014-10-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.