Device Classification Name |
Audiometer
|
510(k) Number |
K913589 |
Device Name |
EARSCAN DSP-1 PURE TONE AUDIOMETER |
Applicant |
MICRO AUDIOMETRICS CORP. |
2200 SO. RIDGEWOOD AVENUE, |
US#1 |
SOUTH DAYTONA,
FL
32119
|
|
Applicant Contact |
LARRY DEDERNARDO |
Correspondent |
MICRO AUDIOMETRICS CORP. |
2200 SO. RIDGEWOOD AVENUE, |
US#1 |
SOUTH DAYTONA,
FL
32119
|
|
Correspondent Contact |
LARRY DEDERNARDO |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 08/12/1991 |
Decision Date | 11/05/1991 |
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
|
|
|