SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY

Display, Cathode-ray Tube, Medical

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Integrated Clinical Display.

Pre-market Notification Details

Device IDK932724
510k NumberK932724
Device Name:SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
ClassificationDisplay, Cathode-ray Tube, Medical
Applicant SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond,  WA  98052
ContactRaymond W Gifford
CorrespondentRaymond W Gifford
SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 Redmond,  WA  98052
Product CodeDXJ  
CFR Regulation Number870.2450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-07
Decision Date1993-11-05

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