FDA.reportPublic FDA data

AliveCor

Matched from indexed company URL: AliveCor, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097159783009715978AliveCor1N2026-01-01189 N Bernardo Avenue Suite 100 Mountain View CA US 94043

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B210AC0110KardiaBand System - The Kardia Band System is a trans-telephonic (transmission by telephone) ECG(electrocardiogram) event recorder that records, stores and transfers single-channelelectrocardiogram rhythms.(855) 338 8800support@alivecor.com
B210AC0110KardiaBand System - The Kardia Band System is a trans-telephonic (transmission by telephone) ECG(electrocardiogram) event recorder that records, stores and transfers single-channelelectrocardiogram rhythms.+4403333010433support@alivecor.com
B210AC0190KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+ - KardiaMobile 6L System is a 3-electrode personal EKG device that is capable of recording two kinds of EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share with your doctor. Both EKG types detect normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and indeterminate results (errors or unclassified rhythms). The KardiaMobile 6L System hardware has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to your smartphone or tablet.(855) 338 8800support@alivecor.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1437891978558227K252589Corvair MonzaMHX2026-01-09
1437891431497822K232035ImpalaDPS2024-06-07
1437891707145681K231010CorvairMHX2024-06-07
1437891268360855K220350KardiaMobile 6LDXH2022-05-25
1437892057854720K220196Steth IO SpotDQD2022-03-24
1437891996493959K212662AliveCor QT ServiceDQK2022-04-26
1437891286640856K211668KardiaMobile CardDXH2021-11-30
1437891320288254K210753KardiaMobile 6LDXH2021-06-30
1437891623384861K201985KardiaAIDQK2020-11-12
1437891361844795K191406KardiaMobile, KardiaStationDXH2020-01-24
1437891182405992K183319Triangle SystemDXH2019-05-10
1437891901728891K182396KardiaMobile, KardiaStationDXH2019-04-12
1437891957031930K181823KardiaAIDQK2019-03-11
1437891644954697K171816Kardia Band SystemDXH2017-11-16
1437892023151681K142743AliveCor Heart MonitorDXH2015-01-27
1437892041072054K142672AliveCor Heart MonitorDXH2014-12-03
1437891439454215K140933ALIVECOR HEART MONITORDXH2014-08-15
1437891083669676K130409ALIVECOR HEART MONITORDPS2013-09-06
1437891537912590K122356ALIVECOR HEART MONITOR FOR IPHONEDPS2012-11-19
1437891222091705

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXH102022-05-25
DPS32024-06-07
DQK32022-04-26
MHX22026-01-09
DQD12022-03-24

PMN#

Impala

2024-06-07

AliveCor, Inc.

GUDID#

KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+ - KardiaMobile 6L System is a 3-electrode personal EKG device that is capable of recording two kinds of EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share with your doctor. Both EKG types detect normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and indeterminate results (errors or unclassified rhythms). The KardiaMobile 6L System hardware has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to your smartphone or tablet.

Alivecor, Inc.

2020-05-01

Kardia 12L - Impala is a portable 12-Lead resting electrocardiograph (ECG) device that acquires 4 ECG leads from a patient, and using software generates the remaining leads to create a 12-lead ECG recording. The device can be used by healthcare professionals (HCPs) to record a diagnostic resting ECG, where traditional 10 electrode 12 lead ECG recorders are not practical due to cost, size, time, or need for specialized clinicians to administer. Examples may include physician offices, “minute clinics”, and remote and field locations, including use by first responders.

Alivecor, Inc.

2024-08-13