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K Number
K961582
Device Name
EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
Manufacturer
NORTH AMERICAN TECHNICAL SERVICES CORP.
Date Cleared
1996-11-08

(198 days)

Product Code
DTC
Regulation Number
870.3630
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.3630 Pacemaker generator function analyzer.

(a)
Identification. A pacemaker generator function analyzer is a device that is connected to a pacemaker pulse generator to test any or all of the generator's parameters, including pulse duration, pulse amplitude, pulse rate, and sensing threshold.(b)
Classification. Class II (performance standards).