HEART*AID 1000

Automated External Defibrillators (non-wearable)

CARDIAC RESUCITATOR CORP.

The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Heart*aid 1000.

Pre-market Notification Details

Device IDK870622
510k NumberK870622
Device Name:HEART*AID 1000
ClassificationAutomated External Defibrillators (non-wearable)
Applicant CARDIAC RESUCITATOR CORP. 12244 S.W. GARDEN PLACE Portland,  OR  97223
ContactJohn L Karpowicz
CorrespondentJohn L Karpowicz
CARDIAC RESUCITATOR CORP. 12244 S.W. GARDEN PLACE Portland,  OR  97223
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-12
Decision Date1987-04-10

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