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510(k) K032386

UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) by Impact Instrumentation, Inc. — Product Code BTL

K032386 is an FDA 510(k) premarket notification submitted by Impact Instrumentation, Inc. for the device "UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)". The FDA issued a decision of Substantially Equivalent on March 26, 2004. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Impact Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2004
Date Received
August 4, 2003
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 Impact Instrumentation, Inc.

  • K133196 — IMPACT MODEL 323 ASPIRATOR (March 10, 2014)
  • K111473 — UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR (February 16, 2012)
  • K103318 — UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR (April 7, 2011)
  • K091238 — UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ (August 13, 2009)
  • K071526 — UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV (December 10, 2008)
  • K051476 — UNI-VENT MODEL 73X (October 28, 2005)
  • K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (May 6, 2003)
  • K951423 — ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT (April 18, 1995)
  • K941096 — ELECTRIC VACUM PUMP (January 5, 1995)
  • K931473 — IMPACT MODEL 753 (December 30, 1994)

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)

FDA data resources