LIFEPAK 12

Automated External Defibrillators (non-wearable)

PHYSIO-CONTROL, INC.

The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Lifepak 12.

Pre-market Notification Details

Device IDK102972
510k NumberK102972
Device Name:LIFEPAK 12
ClassificationAutomated External Defibrillators (non-wearable)
Applicant PHYSIO-CONTROL, INC. 11811 WILLOWS ROAD NORTHEAST P.O. BOX 97006 Redmond,  WA  98073 -9706
ContactMichelle Ackermann
CorrespondentMichelle Ackermann
PHYSIO-CONTROL, INC. 11811 WILLOWS ROAD NORTHEAST P.O. BOX 97006 Redmond,  WA  98073 -9706
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-06
Decision Date2010-12-22
Summary:summary

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