Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K893432 |
Device Name |
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II |
Applicant |
ELECTONE, INC. |
P.O. BOX 910 |
WINTER PARK,
FL
32790
|
|
Applicant Contact |
MINARD FREANT |
Correspondent |
ELECTONE, INC. |
P.O. BOX 910 |
WINTER PARK,
FL
32790
|
|
Correspondent Contact |
MINARD FREANT |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/02/1989 |
Decision Date | 08/04/1989 |
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
|
|
|