ACTITRAC


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K992410
Device Name ACTITRAC
Applicant
INDIVIDUAL MONITORING SYSTEMS, INC.
1055 taylor ave., suite 300
baltimore, 
MD 
21286 -8334

Applicant Contact david t krausman
Correspondent
INDIVIDUAL MONITORING SYSTEMS, INC.
1055 taylor ave., suite 300
baltimore, 
MD 
21286 -8334

Correspodent Contact david t krausman
Regulation Number 882.1400
Classification Product Code
GWQ  
Date Received 07/20/1999
Decision Date 10/15/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No