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510(k) K841537

IMPACT MODEL 601 by Impact Instrumentation, Inc. — Product Code BTI

K841537 is an FDA 510(k) premarket notification submitted by Impact Instrumentation, Inc. for the device "IMPACT MODEL 601". The FDA issued a decision of Substantially Equivalent on May 31, 1984. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Impact Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1984
Date Received
April 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
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)
  • 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)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources