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510(k) K933726

MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM by Augustine Medical, Inc. — Product Code LHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
August 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type

Other clearances by Augustine Medical, Inc.

  • K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (July 9, 2002)
  • K020077 — MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (January 31, 2002)
  • K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MO (September 6, 2000)
  • K973741 — BAIR HUGGER BLOOD/FLUID WARMER (April 30, 1998)
  • K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET (June 26, 1997)
  • K963293 — AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (March 28, 1997)
  • K963672 — MODEL 90022 ROLLING STAND (January 6, 1997)
  • K960167 — SYSTEM, THERMAL REGULATING 74-DWJ (June 17, 1996)
  • K954446 — AUGUSTINE INTUBATION GUIDE (December 29, 1995)
  • K952864 — BAIR HUGGER MODEL 655 BLANKET (September 12, 1995)

Other clearances for product code LHC

  • K153713 — Getinge Series Warming Cabinet (June 7, 2016)
  • K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (January 15, 2016)
  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K083417 — INTRATEMP SOLUTION WARMER (January 13, 2009)
  • K080609 — SWC/DWC WARMING CABINETS (June 13, 2008)
  • K051819 — C CHANGE SOLUTION WARMER (August 15, 2005)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)