BIOSOMNIA


Device Classification Name

reduced- montage standard electroencephalograph

510(k) Number K021485
Device Name BIOSOMNIA
Original Applicant
OXFORD BIOSIGNALS LIMITED
1468 harwell ave.
crofton, 
MD 
21114 -4341

Original Contact paul a hobday
Regulation Number 882.1400
Classification Product Code
OMC  
Subsequent Product Code
OLV  
Date Received 05/08/2002
Decision Date 09/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No