ACTIWATCH-SCORE


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K991033
Device Name ACTIWATCH-SCORE
Applicant
MINI-MITTER CO., INC.
po box 3386
sunriver, 
OR 
97707

Applicant Contact jack e mckenzie
Correspondent
MINI-MITTER CO., INC.
po box 3386
sunriver, 
OR 
97707

Correspodent Contact jack e mckenzie
Regulation Number 882.1400
Classification Product Code
GWQ  
Date Received 03/29/1999
Decision Date 06/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No