Device Classification Name |
Calibrator, Hearing Aid / Earphone And Analysis Systems
|
510(k) Number |
K861113 |
Device Name |
ER-7C CLINICAL PROBE MICROPHONE |
Applicant |
ETYMOTIC RESEARCH |
61 MARTIN LN. |
ELK GROVE VILLAGE,
IL
60007
|
|
Applicant Contact |
EDWIN L DEVILBISE |
Correspondent |
ETYMOTIC RESEARCH |
61 MARTIN LN. |
ELK GROVE VILLAGE,
IL
60007
|
|
Correspondent Contact |
EDWIN L DEVILBISE |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 03/25/1986 |
Decision Date | 04/23/1986 |
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
|
|
|