Device Classification Name |
tester, auditory impedance
|
510(k) Number |
K081841 |
Device Name |
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER |
Applicant |
AMPLIVOX, LTD. |
P.O. BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
JAY Y KOGOMA |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 06/30/2008 |
Decision Date | 07/16/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|