SIEMENS SC 9000 ETCO2 MODULE

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siemens Sc 9000 Etco2 Module.

Pre-market Notification Details

Device IDK954632
510k NumberK954632
Device Name:SIEMENS SC 9000 ETCO2 MODULE
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers,  MA  01923
ContactThomas Connelly
CorrespondentThomas Connelly
SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers,  MA  01923
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-06
Decision Date1996-02-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049098008167 K954632 000

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