Device Classification Name |
tester, auditory impedance
|
510(k) Number |
K070312 |
Device Name |
EARCHECK ACOUSTIC REFLECTOMETER |
Applicant |
INNOVIA MEDICAL, LLC |
13 RED FOX LANE |
LITTLETON,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
INNOVIA MEDICAL, LLC |
13 RED FOX LANE |
LITTLETON,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 02/01/2007 |
Decision Date | 03/02/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|