Premier Heart L L C

FDA Filings

This page includes the latest FDA filings for Premier Heart L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2438852
FEI Number3003289183
NamePremier Heart, LLC
Owner & OperatorPremier Heart, LLC
Contact Address110 Main Street Suite 201-88
Port Washington NY 11050 US
Official Correspondent
  • Joseph T Shen, MD
  • x-516-8833383-8101
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address110 Main St Suites 201-88
Port Washington, NY 11050 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
PREMIER HEART, LLC
Premier Heart Reusable Limb Clip Electrodes 2024-05-14
PREMIER HEART, LLC
Premier Heart Reusable Limb Clip Electrodes 2024-05-14
PREMIER HEART, LLC
Premier Heart Reusable Limb Clip Electrodes 2024-05-14
PREMIER HEART, LLC
Premier Heart MCG Analysis API 2024-05-13
PREMIER HEART, LLC
Premier Heart MCG Model VH12 2018-06-18
PREMIER HEART, LLC
Premier Heart MCG Analysis Software 2018-06-18
PREMIER HEART, LLC
Premier Heart MCG CF192018-03-29
PREMIER HEART, LLC.
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 88002000-03-21

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