MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180

Tester, Pacemaker Electrode Function

ST JUDE MEDICAL, CRMD

The following data is part of a premarket notification filed by St Jude Medical, Crmd with the FDA for Merlin Psa Patient Cable Ex 3150, Cable Adapter Ex3170, M Adapter Ex3180.

Pre-market Notification Details

Device IDK101982
510k NumberK101982
Device Name:MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
ClassificationTester, Pacemaker Electrode Function
Applicant ST JUDE MEDICAL, CRMD 701 E. EVELYN AVENUE Sunnyvale,  CA  94086
ContactGina Correa
CorrespondentGina Correa
ST JUDE MEDICAL, CRMD 701 E. EVELYN AVENUE Sunnyvale,  CA  94086
Product CodeDTA  
CFR Regulation Number870.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-14
Decision Date2010-12-21
Summary:summary

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