PULSE GENERATOR, R WAVE DEMAND

Implantable Pacemaker Pulse-generator

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Pulse Generator, R Wave Demand.

Pre-market Notification Details

Device IDK790141
510k NumberK790141
Device Name:PULSE GENERATOR, R WAVE DEMAND
ClassificationImplantable Pacemaker Pulse-generator
Applicant PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-19
Decision Date1979-08-10

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