FDA.reportPublic FDA data

Premier Heart, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24388523003289183Premier Heart, LLC1N2026-01-01110 Main St Suites 201-88 Port Washington NY US 11050

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
B320CF190Premier Heart MCG - Premier Heart MCG Field Unit, Model CF19+1 516-883-3383support@premierheart.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
749761141574254K992703CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800DQK2000-03-21
749761604463539

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQK22000-03-21

PMN#

GUDID#