DEFIBRILLATOR LEAD ADAPTER

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

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Defibrillator Lead Adapter.

Pre-market Notification Details

Device IDK905065
510k NumberK905065
Device Name:DEFIBRILLATOR LEAD ADAPTER
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactRaymond W Gifford
CorrespondentRaymond W Gifford
SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-07
Decision Date1991-04-12

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