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510(k) K850671

IMPACT 901 SERIES PORT-A-WALL by Impact Instrumentation, Inc. — Product Code FOX

K850671 is an FDA 510(k) premarket notification submitted by Impact Instrumentation, Inc. for the device "IMPACT 901 SERIES PORT-A-WALL". The FDA issued a decision of Substantially Equivalent on March 11, 1985. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Impact Instrumentation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1985
Date Received
February 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Infusion
Device Class
Class I
Regulation Number
880.6990
Review Panel
HO
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 FOX

  • K980336 — IV STANDS (April 6, 1998)
  • K964782 — MEDRAD CONTRAST HOLDER (February 25, 1997)
  • K961470 — PORT-A-POLE (July 22, 1996)
  • K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER (March 12, 1996)
  • K952196 — IV POLE/STAND (July 31, 1995)
  • K950367 — IV SHUTTLE (April 26, 1995)
  • K946201 — STAND, INFUSION (April 18, 1995)
  • K944580 — FLEXSYS MOBILEMATE EQUIPMENT STAND (March 17, 1995)
  • K932498 — MOBILE CARE IV STAND (October 27, 1993)
  • K925066 — PNEUMATIC IRRIGATION STANDARD (July 28, 1993)

FDA data resources