Device Classification Name |
tester, auditory impedance
|
510(k) Number |
K162210 |
Device Name |
touchTymp |
Applicant |
MAICO DIAGNOSTICS GMBH |
SICKINGENSTR. 70-71 |
BERLIN,
DE
10553
|
|
Applicant Contact |
UWE LEDWORUSKI |
Correspondent |
MAICO DIAGNOSTICS GMBH |
SICKINGENSTR. 70-71 |
BERLIN,
DE
10553
|
|
Correspondent Contact |
UWE LEDWORUSKI |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 08/05/2016 |
Decision Date | 11/16/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|