Device Classification Name |
calculator, drug dose
|
510(k) Number |
K171450 |
Device Name |
Glooko Mobile Insulin Dosing System |
Applicant |
Glooko, Inc |
899 West Evelyn Avenue |
Mountain View,
CA
94041
|
|
Applicant Contact |
Tejasvi Pasi |
Correspondent |
Glooko, Inc |
899 West Evelyn Avenue |
Mountain View,
CA
94041
|
|
Correspondent Contact |
Tejasvi Pasi |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 05/17/2017 |
Decision Date | 02/02/2018 |
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
|
|
|