PONTO PRO POWER


Device Classification Name

hearing aid, bone conduction

510(k) Number K103594
Device Name PONTO PRO POWER
Applicant
OTICON MEDICAL AB
ekonomiv 2
gothenburg, askim, 

SE

se-436 33

Applicant Contact ulrika nielsen
Correspondent
OTICON MEDICAL AB
ekonomiv 2
gothenburg, askim, 

SE

se-436 33

Correspodent Contact ulrika nielsen
Regulation Number 874.3300
Classification Product Code
LXB  
Date Received 12/08/2010
Decision Date 06/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No