EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100

Analyzer, Pacemaker Generator Function

NORTH AMERICAN TECHNICAL SERVICES CORP.

The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for External Pacemaker Analyzer, Model Pmt 100.

Pre-market Notification Details

Device IDK961582
510k NumberK961582
Device Name:EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
ClassificationAnalyzer, Pacemaker Generator Function
Applicant NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach,  NY  11789 -1734
ContactRichard C Lanzillotto
CorrespondentRichard C Lanzillotto
NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach,  NY  11789 -1734
Product CodeDTC  
CFR Regulation Number870.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-24
Decision Date1996-11-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B3359500 K961582 000
B3359600 K961582 000
B33596020000 K961582 000

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