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510(k) K855004

SWELL-RELIEF by D.A. Schulman, Inc. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1986
Date Received
December 13, 1985
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 D.A. Schulman, Inc.

  • K883681 — DAS SPORT PUMP(TM) (September 30, 1988)
  • K872739 — SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION (July 30, 1987)
  • K831247 — SAFE-SEAT WHEELCHAIR CUSHION (May 16, 1983)

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)