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510(k) Data Aggregation
K Number
K002976Device Name
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXXManufacturer
Date Cleared
2000-12-22
(88 days)
Product Code
Regulation Number
870.1220Type
TraditionalPanel
Cardiovascular (CV)Reference & Predicate Devices
N/A
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Device Name :
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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