SPACELABS MODEL 90419 PULSE OXIMETER MODULE

Oximeter

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Model 90419 Pulse Oximeter Module.

Pre-market Notification Details

Device IDK864279
510k NumberK864279
Device Name:SPACELABS MODEL 90419 PULSE OXIMETER MODULE
ClassificationOximeter
Applicant SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
ContactAllen Hans
CorrespondentAllen Hans
SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth,  CA  91311
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-30
Decision Date1987-03-11

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