DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES

Index-generating Electroencephalograph Software

DATEX-OHMEDA

The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda S/5 Bis Module, M-bis And Accessories.

Pre-market Notification Details

Device IDK013389
510k NumberK013389
Device Name:DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
ClassificationIndex-generating Electroencephalograph Software
Applicant DATEX-OHMEDA 86 PILGRIM RD. Needham,  MA  02492
ContactJoel Kent
CorrespondentJoel Kent
DATEX-OHMEDA 86 PILGRIM RD. Needham,  MA  02492
Product CodeOLW  
Subsequent Product CodeOMC
Subsequent Product CodeORT
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-12
Decision Date2002-01-10
Summary:summary

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