OBC BONE ANCHORED HEARING SYSTEM


Device Classification Name

hearing aid, bone conduction, implanted

510(k) Number K112053
Device Name OBC BONE ANCHORED HEARING SYSTEM
Applicant
OTICON MEDICAL AB
ekonomivagen 2
askim, 

SE

se-436 33

Applicant Contact karolin isberg jernby
Correspondent
OTICON MEDICAL AB
ekonomivagen 2
askim, 

SE

se-436 33

Correspodent Contact karolin isberg jernby
Regulation Number 874.3300
Classification Product Code
MAH  
Date Received 07/19/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No