Device Classification Name |
Calculator, Drug Dose
|
510(k) Number |
K161433 |
Device Name |
Insulia Diabetes Management Companion |
Applicant |
VOLUNTIS S.A. |
58, AVENUE DE WAGRAM |
Paris,
FR
75017
|
|
Applicant Contact |
RAFFI KRIKORIAN |
Correspondent |
VOLUNTIS S.A. |
2, RUE DES BOURETS |
Suresnes,
FR
92150
|
|
Correspondent Contact |
RAFFI KRIKORIAN |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 05/24/2016 |
Decision Date | 11/09/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|