Medical Device Manufacturer · US , San Francisco , CA

AliveCor, Inc.

19 submissions · 19 cleared · Since 2012
19
Total
19
Cleared
0
Denied

AliveCor, Inc. — FDA 510(k) Submissions

AliveCor, Inc. has submitted 19 FDA 510(k) premarket notifications since 2012, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Transmitters And Receivers, Electrocardiograph, Telephone, Electrocardiograph, Computer, Diagnostic, Programmable, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
Corvair Monza
K252589 · MHX Monitor, Physiological,... · Cardiovascular
Jan 2026 147d
Corvair
K231010 · MHX Monitor, Physiological,... · Cardiovascular
Jun 2024 427d
Impala
K232035 · DPS Electrocardiograph · Cardiovascular
Jun 2024 336d
KardiaMobile 6L
K220350 · DXH Transmitters And... · Cardiovascular
May 2022 107d
AliveCor QT Service
K212662 · DQK Computer, Diagnostic,... · Cardiovascular
Apr 2022 246d
KardiaMobile Card
K211668 · DXH Transmitters And... · Cardiovascular
Nov 2021 182d
KardiaMobile 6L
K210753 · DXH Transmitters And... · Cardiovascular
Jun 2021 107d
KardiaAI
K201985 · DQK Computer, Diagnostic,... · Cardiovascular
Nov 2020 118d
KardiaMobile, KardiaStation
K191406 · DXH Transmitters And... · Cardiovascular
Jan 2020 241d
Triangle System
K183319 · DXH Transmitters And... · Cardiovascular
May 2019 161d
KardiaMobile, KardiaStation
K182396 · DXH Transmitters And... · Cardiovascular
Apr 2019 220d
KardiaAI
K181823 · DQK Computer, Diagnostic,... · Cardiovascular
Mar 2019 245d
Kardia Band System
K171816 · DXH Transmitters And... · Cardiovascular
Nov 2017 150d
AliveCor Heart Monitor
K142743 · DXH Transmitters And... · Cardiovascular
Jan 2015 125d
AliveCor Heart Monitor
K142672 · DXH Transmitters And... · Cardiovascular
Dec 2014 75d
ALIVECOR HEART MONITOR
K140933 · DXH Transmitters And... · Cardiovascular
Aug 2014 126d
ALIVECOR HEART MONITOR OTC
K130921 · DPS Electrocardiograph · Cardiovascular
Feb 2014 309d
ALIVECOR HEART MONITOR
K130409 · DPS Electrocardiograph · Cardiovascular
Sep 2013 199d
ALIVECOR HEART MONITOR FOR IPHONE
K122356 · DPS Electrocardiograph · Cardiovascular
Nov 2012 108d
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