FDA.reportPublic FDA data

BARDY DIAGNOSTICS, INC.

Matched from indexed company URL: Bardy Diagnostics, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30142267073014226707BARDY DIAGNOSTICS, INC.1N2026-01-01220 120th Avenue NE, Suite 100 Bellevue WA US 98005
30142267073014226707BARDY DIAGNOSTICS, INC.1N2020-04-25316 Occidental Ave S, Suite B310 Seattle WA US 98104

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3013471983962589K233110Carnation Ambulatory MonitorDSH2023-11-22
1828401412890893K191471Carnation Ambulatory MonitorDSH2019-08-30
1828401699580176K191000Carnation Ambulatory MonitorDSH2019-05-16
1828401834888052K143067Carnation Ambulatory MonitorDSH2014-12-22
3013471820976957

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSH42023-11-22

PMN#

GUDID#