SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION

Recorder, Magnetic Tape, Medical

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelab Model 90845 Pcms Multidisclosure Station.

Pre-market Notification Details

Device IDK913038
510k NumberK913038
Device Name:SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION
ClassificationRecorder, Magnetic Tape, Medical
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 CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-09
Decision Date1991-10-04

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