Device Classification Name |
Tympanometer
|
510(k) Number |
K150163 |
Device Name |
Otowave 202 Portable Tympanometer |
Applicant |
AMPLIVOX, LTD. |
6 Oasis Park |
Eynsham,
GB
OX29 4tp
|
|
Applicant Contact |
Chris Roerig |
Correspondent |
Kamm & Associates |
8870 RAVELLO CT. |
NAPLES,
FL
34114
|
|
Correspondent Contact |
Daniel Kamm |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 01/26/2015 |
Decision Date | 04/23/2015 |
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
|
|
|