PERMOBIL M300 / M400


Device Classification Name

wheelchair, powered

510(k) Number K103477
Device Name PERMOBIL M300 / M400
Applicant
PERMOBIL AB
box 120
timra, 

SE

s-861 23

Applicant Contact jan astrom
Correspondent
PERMOBIL AB
box 120
timra, 

SE

s-861 23

Correspodent Contact jan astrom
Regulation Number 890.3860
Classification Product Code
ITI  
Date Received 11/26/2010
Decision Date 03/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No