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510(k) K972525

THUMPER by Michigan Instruments, Inc. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1997
Date Received
July 7, 1997
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 Michigan Instruments, Inc.

  • K073079 — THUMPER, MODEL: 1008 (February 14, 2008)
  • K962237 — THUMPER CARDIOPULMONARY RESUSCITATOR (September 5, 1996)
  • K895954 — LARYNGOSTAT LARYNGOSCOPE HANDLE (October 30, 1989)
  • K851139 — THUMPER CARDIOPULMONARY RESUSCITATOR 1005 (May 15, 1985)
  • K833879 — CARDIOPULMONARY RESUSCITATOR (December 27, 1983)
  • K811909 — CARDIOPULMUNARY RESUSCITATOR (July 16, 1981)

Other clearances for product code DRM

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  • K211289 — RMU-2000 Automated Chest Compression System (November 9, 2021)
  • 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)