CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE

Oximeter

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Cardiac Outpur/saturated Venous Oxygen Module.

Pre-market Notification Details

Device IDK893867
510k NumberK893867
Device Name:CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE
ClassificationOximeter
Applicant SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactRaymond Gifford
CorrespondentRaymond Gifford
SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-26
Decision Date1989-09-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522106293 K893867 000

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