AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON


Device Classification Name

hearing aid, bone conduction

510(k) Number K121793
Device Name AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
Applicant
AUDIFON-USA INC.
403 chairman ct., ste. 1
debary, 
FL 
32713

Applicant Contact jane e perrone
Correspondent
AUDIFON-USA INC.
403 chairman ct., ste. 1
debary, 
FL 
32713

Correspodent Contact jane e perrone
Regulation Number 874.3300
Classification Product Code
LXB  
Date Received 06/19/2012
Decision Date 11/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No