K Number
K954401Device Name
GASTROTECManufacturer
Date Cleared
1996-04-25
(218 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
ENReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A