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 |