ANALYZER, PACER SYSTEM, PSA-5

Analyzer, Pacemaker Generator Function

EDWARDS PACEMAKER SYSTEMS

The following data is part of a premarket notification filed by Edwards Pacemaker Systems with the FDA for Analyzer, Pacer System, Psa-5.

Pre-market Notification Details

Device IDK781144
510k NumberK781144
Device Name:ANALYZER, PACER SYSTEM, PSA-5
ClassificationAnalyzer, Pacemaker Generator Function
Applicant EDWARDS PACEMAKER SYSTEMS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTC  
CFR Regulation Number870.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-07-10
Decision Date1978-08-23

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