KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

KONTRON INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Capnograph Monitor, Supermon Module 7281.

Pre-market Notification Details

Device IDK873396
510k NumberK873396
Device Name:KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett,  MA  02149
ContactDavid Cromwick
CorrespondentDavid Cromwick
KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett,  MA  02149
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-24
Decision Date1988-06-21

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