Device Classification Name |
Audiometer
|
510(k) Number |
K191372 |
Device Name |
Lyra |
Applicant |
Interacoustics A/S |
Audiometer Alle 1 |
Middelfart,
DK
DK-5500
|
|
Applicant Contact |
Erik Nielsen |
Correspondent |
Interacoustics A/S |
Audiometer Alle 1 |
Middelfart,
DK
DK-5500
|
|
Correspondent Contact |
Erik Nielsen |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 05/22/2019 |
Decision Date | 07/15/2019 |
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
|
|
|