CAPELLA


definition

Device Classification Name

audiometer

510(k) Number K002200
Device Name CAPELLA
Original Applicant
MADSEN ELECTRONICS, INC.
5600 rowland rd., suite 275
minnetonka, 
MN 
55343

Original Contact jim bergerson
Regulation Number 874.1050
Classification Product Code
EWO  
Date Received 07/20/2000
Decision Date 08/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No