Device Classification Name |
Calibrator, Hearing Aid / Earphone And Analysis Systems
|
510(k) Number |
K853271 |
Device Name |
HEARING AID ANALYSIS SYSTEM |
Applicant |
ROBERT BOSCH CORP. |
FLOWER FIELD BLDG. #17 |
MILL POND ROAD |
ST. JAMES,
NY
11780
|
|
Applicant Contact |
CHERYL M LEISTER |
Correspondent |
ROBERT BOSCH CORP. |
FLOWER FIELD BLDG. #17 |
MILL POND ROAD |
ST. JAMES,
NY
11780
|
|
Correspondent Contact |
CHERYL M LEISTER |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 08/05/1985 |
Decision Date | 01/16/1986 |
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
|
|
|