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


Device Classification Name

index-generating electroencephalograph software

510(k) Number K023459
Device Name DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
Original Applicant
DATEX-OHMEDA
86 pilgrim rd.
needham, 
MA 
02492

Original Contact joel kent
Regulation Number 882.1400
Classification Product Code
OLW  
Subsequent Product Codes
GXY   OMC   ORT  
Date Received 10/15/2002
Decision Date 01/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No