AMENDMENT LIFEPAK 8, NPN 052

Pacemaker, Cardiac, External Transcutaneous (non-invasive)

PHYSIO-CONTROL CORP.

The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Amendment Lifepak 8, Npn 052.

Pre-market Notification Details

Device IDK854117
510k NumberK854117
Device Name:AMENDMENT LIFEPAK 8, NPN 052
ClassificationPacemaker, Cardiac, External Transcutaneous (non-invasive)
Applicant PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond,  WA  98073 -9706
ContactMichael B Gropp
CorrespondentMichael B Gropp
PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond,  WA  98073 -9706
Product CodeDRO  
CFR Regulation Number870.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-10-09
Decision Date1986-01-13

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