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K Number
K963579

Validate with FDA (Live)

Device Name
PACE-1A CARDIAC STIMULATOR
Manufacturer
RADIONICS, INC.
Date Cleared
1996-11-08

(63 days)

Product Code
JOQ
Regulation Number
870.1750
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.1750 External programmable pacemaker pulse generator.

(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).