Device Classification Name |
hearing aid, group and auditory trainer
|
510(k) Number |
K915397 |
Device Name |
TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER |
Applicant |
TELEX COMMUNICATIONS, INC. |
9600 ALDRICH AVENUE SOUTH |
MINNEAPOLIS,
MN
55420
|
|
Applicant Contact |
THOMAS LAKE |
Correspondent |
TELEX COMMUNICATIONS, INC. |
9600 ALDRICH AVENUE SOUTH |
MINNEAPOLIS,
MN
55420
|
|
Correspondent Contact |
THOMAS LAKE |
Regulation Number | 874.3320
|
Classification Product Code |
|
Date Received | 11/29/1991 |
Decision Date | 01/17/1992 |
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
|
|
|