FDA.reportPublic FDA data

AliveCor

FDA Registration(s)#

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

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