MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM— 510(k) K933726

Name: FDA 510(k) clearance K933726
Creator: U.S. Food and Drug Administration
Published: 1994-01-28

Substantially Equivalent

Augustine Medical, Inc.

FDA 510(k) clearance K933726 for MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM, Substantially Equivalent on 1994-01-28. Applicant: Augustine Medical, Inc.. Device class: 1.

Clearance details

Applicant: Augustine Medical, Inc.
Product code: Code LHC
Device class: Class 1
Regulation: 21 CFR 890.5950
Advisory panel: Physical Medicine
Date received: 1993-08-02
Decision date: 1994-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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K153713 — Getinge Series Warming Cabinet2016-06-07
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K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE2014-12-30
K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED2014-08-28

More clearances from Augustine Medical, Inc.

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K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM2002-07-09
K020077 — MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX2002-01-31
K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK2000-09-06
K973741 — BAIR HUGGER BLOOD/FLUID WARMER1998-04-30
K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET1997-06-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.