Device Classification Name |
Tester, Auditory Impedance
|
510(k) Number |
K994254 |
Device Name |
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER |
Applicant |
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI |
4814 EAST SECOND ST. |
BENICIA,
CA
94510
|
|
Applicant Contact |
DONNA WARD |
Correspondent |
INTERNATIONAL DISTRIBUTORS OF ELECTRONICS FOR MEDI |
4814 EAST SECOND ST. |
BENICIA,
CA
94510
|
|
Correspondent Contact |
DONNA WARD |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 12/17/1999 |
Decision Date | 03/14/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|