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510(k) Data Aggregation
K Number
K964377Device Name
THERMAL REGULATION SYSTEM BLANKETManufacturer
Date Cleared
1997-04-23
(173 days)
Product Code
Regulation Number
870.5900Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
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Device Name :
THERMAL REGULATION SYSTEM BLANKET
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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