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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name index-generating electroencephalograph software
510(k) Number K013389
Device Name DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
Applicant
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Applicant Contact JOEL KENT
Correspondent
DATEX-OHMEDA
86 PILGRIM RD.
NEEDHAM,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received10/12/2001
Decision Date 01/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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