TEMPORARY PACEMAKER ELECTRODE

Electrode, Pacemaker, Temporary

OSCOR MEDICAL CORP.

The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Temporary Pacemaker Electrode.

Pre-market Notification Details

Device IDK872972
510k NumberK872972
Device Name:TEMPORARY PACEMAKER ELECTRODE
ClassificationElectrode, Pacemaker, Temporary
Applicant OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor,  FL  33563
ContactBrian K Cornish
CorrespondentBrian K Cornish
OSCOR MEDICAL CORP. 2311 US ALT. 19N. P.O. BOX 459 Palm Harbor,  FL  33563
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-29
Decision Date1987-12-03

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