510(k) K964673

BAIR HUGGER MODEL 630 CARDIAC BLANKET by Augustine Medical, Inc. — Product Code DWJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 26, 1997
Date Received: November 21, 1996
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Thermal Regulating
Device Class: Class II
Regulation Number: 870.5900
Review Panel: CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
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)
K950416 — BAIR HUGGER MODEL 600 UNIT, BLANKETS (August 29, 1995)

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