MODEL 90421 FLEXPORT INTERFACE

Oximeter

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Model 90421 Flexport Interface.

Pre-market Notification Details

Device IDK903702
510k NumberK903702
Device Name:MODEL 90421 FLEXPORT INTERFACE
ClassificationOximeter
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 CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-31
Decision Date1990-10-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522105098 K903702 000
10841522106316 K903702 000
10841522106323 K903702 000
10841522106330 K903702 000
10841522106347 K903702 000
10841522106361 K903702 000
10841522106378 K903702 000
10841522106392 K903702 000
10841522106408 K903702 000
10841522105128 K903702 000
10841522105135 K903702 000
10841522105142 K903702 000
10841522105159 K903702 000
10841522105180 K903702 000
10841522129063 K903702 000
10841522100062 K903702 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.