The following data is part of a premarket notification filed by Philosys Inc. with the FDA for Gmate Smart Blood Glucose Monitoring System.
| Device ID | K150299 |
| 510k Number | K150299 |
| Device Name: | Gmate SMART Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Philosys Inc. 304 Park Avenue South, Suite 218 New York, NY 10010 |
| Contact | Linda Chan |
| Correspondent | Linda Chan Philosys Inc. 304 Park Avenue South, Suite 218 New York, NY 10010 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-06 |
| Decision Date | 2015-11-19 |
| Summary: | summary |