BIOSLEEP


Device Classification Name

automatic event detection software for polysomnograph with electroencephalograph

510(k) Number K002622
Device Name BIOSLEEP
Original Applicant
OXFORD BIOSIGNALS LIMITED
oxford science park
oxford, ox4 4 ga, 

GB

ox4 4

Original Contact pauline a hobday
Regulation Number 882.1400
Classification Product Code
OLZ  
Date Received 08/23/2000
Decision Date 10/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No