SPACELABS MEDICAL DISPOSABLE SP02 SENSOR

Oximeter

SPACELABS MEDICAL, INC.

The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Disposable Sp02 Sensor.

Pre-market Notification Details

Device IDK981655
510k NumberK981655
Device Name:SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
ClassificationOximeter
Applicant SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond,  WA  98073 -9713
ContactNancy Gertlar
CorrespondentNancy Gertlar
SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond,  WA  98073 -9713
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-11
Decision Date1999-12-03
Summary:summary

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