Medical Device Manufacturer · US , Mchenry , IL

Impact Instrumentation, Inc. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1981

Recent clearances: IMPACT MODEL 323 ASPIRATOR, UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR, UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR

27

Total

27

Cleared

0

Denied

FDA 510(k) Regulatory Record - Impact Instrumentation, Inc. Anesthesiology ✕

15 devices

1-15 of 15

Cleared Feb 16, 2012

UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR

Anesthesiology · 265d

Cleared Apr 07, 2011

UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR

Anesthesiology · 146d

Cleared Aug 13, 2009

UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+

Anesthesiology · 108d

Cleared Dec 10, 2008

UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV

Anesthesiology · 555d

Cleared Oct 28, 2005

UNI-VENT MODEL 73X

Anesthesiology · 147d

Cleared Mar 26, 2004

UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)

Anesthesiology · 235d

Cleared May 06, 2003

IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00

Anesthesiology · 315d

Cleared Dec 30, 1994

IMPACT MODEL 753

Anesthesiology · 646d

Cleared Dec 27, 1990

POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE

Anesthesiology · 3d

Cleared Jan 19, 1988

UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR

Anesthesiology · 322d

Cleared May 20, 1986

IMPACT MODELS 701, 702 AND 703

Anesthesiology · 46d

Cleared May 31, 1984

IMPACT MODEL 601

Anesthesiology · 45d

Cleared Jun 02, 1981

RESPIRATORY SENSOR

Anesthesiology · 48d

Cleared Jun 02, 1981

RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)

Anesthesiology · 21d

Cleared Mar 31, 1981

AIRWAY PRESSURE MONITOR

Anesthesiology · 11d