IMPLANTABLE PROGRAMMABLE PULSE GENER

Implantable Pacemaker Pulse-generator

TELECTRONICS, INC.

The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Implantable Programmable Pulse Gener.

Pre-market Notification Details

Device IDK840737
510k NumberK840737
Device Name:IMPLANTABLE PROGRAMMABLE PULSE GENER
ClassificationImplantable Pacemaker Pulse-generator
Applicant TELECTRONICS, INC. 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 Received1984-02-21
Decision Date1984-05-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.