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510(k) K011046

AUTOPULSE, MODEL 100 by Revivant Corp. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2001
Date Received
April 6, 2001
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 Revivant Corp.

  • K040453 — AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (March 11, 2004)
  • K032852 — MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 (November 12, 2003)
  • K022345 — AUTOPULSE RESUSCITATION SYSTEM (August 15, 2002)

Other clearances for product code DRM

  • K221700 — AutoPulse NXT Resuscitation System (March 9, 2023)
  • 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)