ACTIWARE-PLMS


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K011430
Device Name ACTIWARE-PLMS
Original Applicant
MINI-MITTER CO., INC.
20300 empire ave. bldg. b-3
bend, 
OR 
97701

Original Contact jack e mckenzie
Regulation Number 882.1400
Classification Product Code
GWQ  
Date Received 05/09/2001
Decision Date 05/31/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

Type Special
Reviewed by Third Party No

Combination Product

No