Device Classification Name |
Tester, Auditory Impedance
|
510(k) Number |
K930165 |
Device Name |
AE-207D TYMPANOMETER |
Applicant |
AMREX ELECTRONICS, INC. |
13 COLUMBIA DR. |
SUITE 18 |
AMHERST,
NH
03031
|
|
Applicant Contact |
NOEL WREN |
Correspondent |
AMREX ELECTRONICS, INC. |
13 COLUMBIA DR. |
SUITE 18 |
AMHERST,
NH
03031
|
|
Correspondent Contact |
NOEL WREN |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 01/13/1993 |
Decision Date | 04/23/1993 |
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
|
|
|