Device Classification Name |
Audiometer
|
510(k) Number |
K171506 |
Device Name |
Easyscreen |
Applicant |
Maico Diagnostics GmbH |
Sickingenstr. 70-71 |
Berlin,
DE
10553
|
|
Applicant Contact |
Amy Yanta |
Correspondent |
Maico Diagnostics GmbH |
Sickingenstr. 70-71 |
Berlin,
DE
10553
|
|
Correspondent Contact |
Amy Yanta |
Regulation Number | 874.1050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/23/2017 |
Decision Date | 08/29/2017 |
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
|
|
|