OMNIPRO SYSTEM


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K050143
Device Name OMNIPRO SYSTEM
Applicant
MAYS AND ASSOCIATES, INC.
11874 south evelyn circle
houston, 
TX 
77071 -3404

Applicant Contact harvey knauss
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received 01/21/2005
Decision Date 02/01/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No