DATEX-OHMEDA NETWORK AND CENTRAL

System, Network And Communication, Physiological Monitors

DATEX-OHMEDA, INC.

The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Network And Central.

Pre-market Notification Details

Device IDK000647
510k NumberK000647
Device Name:DATEX-OHMEDA NETWORK AND CENTRAL
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury,  MA  01876
ContactJoel Kent
CorrespondentJoel Kent
DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury,  MA  01876
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-28
Decision Date2000-07-13

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