Device Classification Name |
audiometer
|
510(k) Number |
K874516 |
Device Name |
MODEL V4 AUDIOMETER |
Applicant |
DIGITAL HEARING SYSTEMS CORP. |
2934 SHADY LN. |
ANN ARBOR,
MI
48104
|
|
Applicant Contact |
J MILTICH,II |
Correspondent |
DIGITAL HEARING SYSTEMS CORP. |
2934 SHADY LN. |
ANN ARBOR,
MI
48104
|
|
Correspondent Contact |
J MILTICH,II |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 11/02/1987 |
Decision Date | 12/14/1987 |
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
|
|
|