MODEL 90489 PULSE OXIMETER MODULE

Oximeter

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Model 90489 Pulse Oximeter Module.

Pre-market Notification Details

Device IDK901209
510k NumberK901209
Device Name:MODEL 90489 PULSE OXIMETER MODULE
ClassificationOximeter
Applicant SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactW Gifford
CorrespondentW 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 Received1990-03-14
Decision Date1990-04-30

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