Device Classification Name |
audiometer
|
510(k) Number |
K982642 |
Device Name |
ECHO-SCREEN |
Applicant |
FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. |
11309 BRANDON PARK DR., #B |
SANDY,
UT
84092
|
|
Applicant Contact |
DAVID G WOOD |
Correspondent |
FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. |
11309 BRANDON PARK DR., #B |
SANDY,
UT
84092
|
|
Correspondent Contact |
DAVID G WOOD |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 07/29/1998 |
Decision Date | 10/21/1998 |
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
|
|
|