FDA.reportPublic FDA data

CARDIAC INSIGHT, INC.

Matched from indexed company URL: Cardiac Insight, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103426163010342616CARDIAC INSIGHT, INC.1N2026-01-012375 130th Ave NE Suite 101 Bellevue WA US 98005

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
00857553006009CardeaScreen - CardeaScreen is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subsequent analysis of the patient's ECG data.2065962060info@cardiacinsightinc.com
00857553006016Cardea 20/20 ECG - Cardea 20/20 ECG is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subsequent analysis of the patient's ECG data.2065962060info@cardiacinsightinc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1597111123300719K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareDSH2017-03-24
1597111371290135K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth SystemDSH2015-07-11
1597111734679869K130288STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICEDSH2013-05-29
1597111129720648K123217CARDEASCREENDPS2013-02-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSH32017-03-24
DPS12013-02-05

PMN#

GUDID#