The following data is part of a premarket notification filed by Glooko, Inc. with the FDA for Glooko Logbook Charts.
| Device ID | K122142 |
| 510k Number | K122142 |
| Device Name: | GLOOKO LOGBOOK CHARTS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | GLOOKO, INC. 170A UNIVERSITY AVENUE Palo Alto, CA 94301 |
| Contact | Shilpa Mydur |
| Correspondent | Shilpa Mydur GLOOKO, INC. 170A UNIVERSITY AVENUE Palo Alto, CA 94301 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-19 |
| Decision Date | 2012-12-21 |
| Summary: | summary |