Device Classification Name |
Tester, Auditory Impedance
|
510(k) Number |
K133013 |
Device Name |
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE |
Applicant |
INVENTIS SRL |
CORSO STATI UNITI 1/3 |
PADOVA,
IT
35127
|
|
Applicant Contact |
MASSIMO MARTINELLI |
Correspondent |
INVENTIS SRL |
CORSO STATI UNITI 1/3 |
PADOVA,
IT
35127
|
|
Correspondent Contact |
MASSIMO MARTINELLI |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 09/25/2013 |
Decision Date | 01/24/2014 |
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
|
|
|