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510(k) K111473

UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR by Impact Instrumentation, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2012
Date Received
May 27, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Impact Instrumentation, Inc.

  • K133196 — IMPACT MODEL 323 ASPIRATOR (March 10, 2014)
  • 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)
  • K032386 — UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) (March 26, 2004)
  • 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)

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