LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR

Automated External Defibrillators (non-wearable)

MEDTRONIC PHYSIO-CONTROL CORP.

The following data is part of a premarket notification filed by Medtronic Physio-control Corp. with the FDA for Lifepak 600 Automated External Defibrillator.

Pre-market Notification Details

Device IDK011144
510k NumberK011144
Device Name:LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
ClassificationAutomated External Defibrillators (non-wearable)
Applicant MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE BX 97006 Redmond,  WA  98073 -9706
ContactSherri L Pocock
CorrespondentSherri L Pocock
MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE BX 97006 Redmond,  WA  98073 -9706
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-16
Decision Date2001-12-03

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