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510(k) K211289

RMU-2000 Automated Chest Compression System by Defibtech, LLC — Product Code DRM

K211289 is an FDA 510(k) premarket notification submitted by Defibtech, LLC for the device "RMU-2000 Automated Chest Compression System". The FDA issued a decision of Substantially Equivalent on November 9, 2021. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200. Defibtech, LLC has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2021
Date Received
April 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type

Other clearances by Defibtech, LLC

  • K141809 — RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (October 27, 2014)
  • K131525 — SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (April 24, 2014)
  • K113787 — DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (January 4, 2013)
  • K121853 — DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (December 13, 2012)
  • K081259 — DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES (June 15, 2009)
  • K033896 — DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WIT (June 16, 2004)
  • K033144 — DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES (November 13, 2003)
  • K013896 — SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECT (June 19, 2002)

Other clearances for product code DRM

  • K221700 — AutoPulse NXT Resuscitation System (March 9, 2023)
  • K173553 — LUCAS 3 Chest Compression System (February 8, 2018)
  • K161768 — LUCAS 3 Chest Compression System (November 9, 2016)
  • K153628 — ROSC-U Mini Chest Compressor (RMCC) (January 30, 2016)
  • K141809 — RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (October 27, 2014)
  • K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (March 15, 2012)
  • K102068 — MINIATURIZE CHEST COMPRESSOR (MCC) (November 16, 2010)
  • K090422 — LUCAS 2 (June 17, 2009)
  • K072527 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (March 19, 2008)
  • K073079 — THUMPER, MODEL: 1008 (February 14, 2008)

FDA data resources