SPACELABS' MODEL 90514, MULTIGAS ANALYZER

Analyzer, Gas, Oxygen, Gaseous-phase

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs' Model 90514, Multigas Analyzer.

Pre-market Notification Details

Device IDK896427
510k NumberK896427
Device Name:SPACELABS' MODEL 90514, MULTIGAS ANALYZER
ClassificationAnalyzer, Gas, Oxygen, Gaseous-phase
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 CodeCCL  
CFR Regulation Number868.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-08
Decision Date1990-01-24

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