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K Number
K001149
Device Name
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
Manufacturer
AUGUSTINE MEDICAL, INC.
Date Cleared
2000-09-06

(149 days)

Product Code
DWJ
Regulation Number
870.5900
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K040440,K041686,K052392,K062794,K080763,K092807,K101705,K102856,K141686,K162562,K171373
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).