Device Classification Name |
Tester, Auditory Impedance
|
510(k) Number |
K971859 |
Device Name |
EARCHECK |
Applicant |
MDI INSTRUMENTS, INC. |
200 UNICORE PARK DR. |
WOBURN,
MA
01801
|
|
Applicant Contact |
SANDRA KIMBALL |
Correspondent |
MDI INSTRUMENTS, INC. |
200 UNICORE PARK DR. |
WOBURN,
MA
01801
|
|
Correspondent Contact |
SANDRA KIMBALL |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 05/20/1997 |
Decision Date | 08/18/1997 |
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
|
|
|