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Premier Heart MCG CF19

by Premier Heart, LLC

Premier Heart MCG CF19 is a Class II device made by Premier Heart, LLC, listed in FDA GUDID since 27 Sep 2016 (UDI-DI B320CF190), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB320CF190 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Premier Heart MCG
Generic name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / Ref / Catalog
CF19
Primary DI / UDI-DI
B320CF190
FDA product code
DQK
GMDN term
Cardiopulmonary physiological parameter analysis software, professional-only
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Electrocardiograph, professional, multichannelCardiopulmonary physiological parameter analysis software

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Other devices filed under Cardiopulmonary physiological parameter analysis software.

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Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)