The following data is part of a premarket notification filed by Foracare Inc. with the FDA for Fora Gtel Blood Glucose Monitoring System.
| Device ID | K173505 |
| 510k Number | K173505 |
| Device Name: | FORA GTel Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ForaCare Inc. 893 Patriot Dr. Suite D Moorpark, CA 93021 |
| Contact | Anne Kuo |
| Correspondent | Anne Kuo ForaCare Inc. 893 Patriot Dr. Suite D Moorpark, CA 93021 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001462327 | K173505 | 000 |
| 00850001462037 | K173505 | 000 |
| 00850001462006 | K173505 | 000 |
| 00850001462402 | K173505 | 000 |
| 00850001462129 | K173505 | 000 |
| 00850001462112 | K173505 | 000 |