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K Number
K964377
Device Name
THERMAL REGULATION SYSTEM BLANKET
Manufacturer
GIBECK, INC.
Date Cleared
1997-04-23

(173 days)

Product Code
DWJ
Regulation Number
870.5900
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).