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K Number
K964377

Validate with FDA (Live)

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
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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).