PACEPAC

Pacemaker, Cardiac, External Transcutaneous (non-invasive)

MEDICAL DATA ELECTRONICS

The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Pacepac.

Pre-market Notification Details

Device IDK852958
510k NumberK852958
Device Name:PACEPAC
ClassificationPacemaker, Cardiac, External Transcutaneous (non-invasive)
Applicant MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta,  CA  91331
ContactChip Harlow
CorrespondentChip Harlow
MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta,  CA  91331
Product CodeDRO  
CFR Regulation Number870.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-12
Decision Date1985-10-11

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