CAPNO MODULE, 92517

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

SPACELABS HEALTHCARE

The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Capno Module, 92517.

Pre-market Notification Details

Device IDK130112
510k NumberK130112
Device Name:CAPNO MODULE, 92517
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant SPACELABS HEALTHCARE P.O. BOX 3018 Nederland,  CO  80466
ContactThomas Kroenke
CorrespondentThomas Kroenke
SPACELABS HEALTHCARE P.O. BOX 3018 Nederland,  CO  80466
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-16
Decision Date2013-03-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841522113093 K130112 000
10841522108839 K130112 000

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