MODEL 4000 EEG MONITOR WITH PSI (PSA4000)


Device Classification Name

index-generating electroencephalograph software

510(k) Number K001069
Device Name MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
Original Applicant
PHYSIOMETRIX, INC.
five billerica park,
101 billerica ave.
north billerica, 
MA 
01862

Original Contact dawn e frazer
Regulation Number 882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received 04/03/2000
Decision Date 06/30/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No