NEOS - PULSE GENERATOR

Implantable Pacemaker Pulse-generator

BIOTRONIK SALES, INC.

The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Neos - Pulse Generator.

Pre-market Notification Details

Device IDK844812
510k NumberK844812
Device Name:NEOS - PULSE GENERATOR
ClassificationImplantable Pacemaker Pulse-generator
Applicant BIOTRONIK SALES, INC. POST OFFICE BOX 1988 Lake Oswego,  OR  97034
ContactCawthon
CorrespondentCawthon
BIOTRONIK SALES, INC. POST OFFICE BOX 1988 Lake Oswego,  OR  97034
Product CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-11
Decision Date1985-04-18

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