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510(k) Data Aggregation
K Number
K010577Device Name
BODYGEM, MODEL HB211Manufacturer
Date Cleared
2002-01-10
(317 days)
Product Code
Regulation Number
868.1730Type
TraditionalPanel
Anesthesiology (AN)Reference & Predicate Devices
N/A
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Device Name :
BODYGEM, MODEL HB211
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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