LIFEPAK 20 DEFIBRILLATOR/ MONITOR

Automated External Defibrillators (non-wearable)

MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.

The following data is part of a premarket notification filed by Medtronic Emergency Response Systems, Inc. with the FDA for Lifepak 20 Defibrillator/ Monitor.

Pre-market Notification Details

Device IDK063119
510k NumberK063119
Device Name:LIFEPAK 20 DEFIBRILLATOR/ MONITOR
ClassificationAutomated External Defibrillators (non-wearable)
Applicant MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 11811 WILLOWS RD., N.E. P.O. BOX 97006 Redmond,  WA  98073 -9706
ContactMichelle Ackermann
CorrespondentMichelle Ackermann
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 11811 WILLOWS RD., N.E. P.O. BOX 97006 Redmond,  WA  98073 -9706
Product CodeMKJ  
Subsequent Product CodeDQA
Subsequent Product CodeDRO
Subsequent Product CodeDRT
Subsequent Product CodeLDD
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-12
Decision Date2006-12-22
Summary:summary

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