PULSE GENERATOR 728, 728B & 728L

Implantable Pacemaker Pulse-generator

SIEMENS ELEMA AB

The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Pulse Generator 728, 728b & 728l.

Pre-market Notification Details

Device IDK841226
510k NumberK841226
Device Name:PULSE GENERATOR 728, 728B & 728L
ClassificationImplantable Pacemaker Pulse-generator
Applicant SIEMENS ELEMA AB 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 Received1984-03-22
Decision Date1984-06-26

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