PHYSICAL MONITORING REGISTRATION UNIT


Device Classification Name

electromyograph, diagnostic

510(k) Number K022719
Device Name PHYSICAL MONITORING REGISTRATION UNIT
Original Applicant
MARYROSE CUSIMANO, PH.D./PHIL REASTON
5367 nw 90th ave.
sunrise, 
FL 
33319

Original Contact maryrose cusimano
Regulation Number 890.1375
Classification Product Code
IKN  
Date Received 08/15/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No