PREMIER HEART, LLC

Address:110 Main St,Port Washington,NY,11050,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Computer, Diagnostic, Programmable (DQK) (3)

Premarket Exempt

Clear

Premier Heart MCG - B320CF190 Catalog Number : CF19

Device Description : Premier Heart MCG Model CF19

Device Class : 2

Duns Number: 109797584

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

Premier Heart MCG Analysis Software - B320MCGC0 Catalog Number :

Device Description : Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client ( Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine

Device Class : 2

Duns Number: 109797584

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

Premier Heart MCG Model VH12 - B320VH120 Catalog Number :

Device Description : Premier Heart MCG 12 Lead capture hardware.

Device Class : 2

Duns Number: 109797584

Premarket Exempt : No

Product Code : DQK

Prescription Use : No

Device Count : 1

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