The following data is part of a premarket notification filed by Glooko, Inc with the FDA for Glooko Mobile Insulin Dosing System.
Device ID | K171450 |
510k Number | K171450 |
Device Name: | Glooko Mobile Insulin Dosing System |
Classification | Calculator, Drug Dose |
Applicant | Glooko, Inc 899 West Evelyn Avenue Mountain View, CA 94041 |
Contact | Tejasvi Pasi |
Correspondent | Tejasvi Pasi Glooko, Inc 899 West Evelyn Avenue Mountain View, CA 94041 |
Product Code | NDC |
CFR Regulation Number | 868.1890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-17 |
Decision Date | 2018-02-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00855093008019 | K171450 | 000 |
00855093008002 | K171450 | 000 |