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510(k) K083385

MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B by Allied Healthcare Products, Inc. — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2009
Date Received
November 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Allied Healthcare Products, Inc.

  • K131098 — EMERGENCY PORTABLE VENTILATOR (April 9, 2014)
  • K132021 — AHP 300, EMERGENCY PORTABLE VENTILATOR (April 2, 2014)
  • K090356 — EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 (May 20, 2009)
  • K083507 — BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS (May 18, 2009)
  • K080063 — MASS CASUALTY VENTILATOR, MODEL MCV100 (August 15, 2008)
  • K072214 — PORTABLE VENTILATOR, MODEL EPV-100 (March 6, 2008)
  • K073171 — RESUSCITATION TIMER, MODEL L770-CPR (January 31, 2008)
  • K070636 — AUTOVENT 4000 WITH CPAP (July 13, 2007)
  • K070120 — AUTOVENT MODEL 4000 (May 3, 2007)
  • K062080 — RESUSCITATION TIMER, MODEL L770-CPR (October 18, 2006)

Other clearances for product code BTL

  • K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (April 4, 2025)
  • K221634 — Oxymag - Transport and Emergency Ventilator (May 24, 2023)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)