HEARTSTART 3000

Automated External Defibrillators (non-wearable)

LAERDAL MEDICAL CORP.

The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Heartstart 3000.

Pre-market Notification Details

Device IDK896919
510k NumberK896919
Device Name:HEARTSTART 3000
ClassificationAutomated External Defibrillators (non-wearable)
Applicant LAERDAL MEDICAL CORP. 12244 S.W. GARDEN PLACE Portland,  OR  97223
ContactJohn Karpowicz
CorrespondentJohn Karpowicz
LAERDAL MEDICAL 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 Received1989-12-12
Decision Date1990-05-03

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