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510(k) Data Aggregation
Device Name
1ST RESPONSE DISPOSABLE MANOMETERManufacturer
Date Cleared
1996-12-17
(256 days)
Product Code
Regulation Number
868.2600Type
TraditionalPanel
AnesthesiologyAge Range
N/A
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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