SPACELABS MODEL 90480 EEG MODULE

Full-montage Standard Electroencephalograph

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Model 90480 Eeg Module.

Pre-market Notification Details

Device IDK896942
510k NumberK896942
Device Name:SPACELABS MODEL 90480 EEG MODULE
ClassificationFull-montage Standard Electroencephalograph
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 CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-13
Decision Date1990-03-08

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