LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED

Dc-defibrillator, Low-energy, (including Paddles)

PHYSIO-CONTROL CORP.

The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifepak 9 Defibrillator & Cardiac Monitor/modified.

Pre-market Notification Details

Device IDK905510
510k NumberK905510
Device Name:LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond,  WA  98073 -9706
ContactD Willingham
CorrespondentD Willingham
PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond,  WA  98073 -9706
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-07
Decision Date1990-12-20

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