540 CAPNOGRAPH

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

SPACELABS, INC.

The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for 540 Capnograph.

Pre-market Notification Details

Device IDK842978
510k NumberK842978
Device Name:540 CAPNOGRAPH
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-30
Decision Date1984-08-24

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