Medical Device Manufacturer · US , Guilford , CT

Defibtech, LLC - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 2002

Recent clearances: RMU-2000 Automated Chest Compression System

9

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Defibtech, LLC Cardiovascular ✕

9 devices

1-9 of 9

Cleared Nov 09, 2021

RMU-2000 Automated Chest Compression System

Cardiovascular · 195d

Cleared Oct 27, 2014

RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM

Cardiovascular · 112d

Cleared Apr 24, 2014

SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

Cardiovascular · 331d

Cleared Jan 04, 2013

DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

Cardiovascular · 379d

Cleared Dec 13, 2012

DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

Cardiovascular · 171d

Cleared Jun 15, 2009

DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

Cardiovascular · 409d

Cleared Jun 16, 2004

DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100...

Cardiovascular · 183d

Cleared Nov 13, 2003

DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES

Cardiovascular · 44d

Cleared Jun 19, 2002

SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR

Cardiovascular · 208d