The following data is part of a premarket notification filed by Philosys Inc. with the FDA for Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring System.
| Device ID | K141656 |
| 510k Number | K141656 |
| Device Name: | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP 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 |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-20 |
| Decision Date | 2015-10-02 |
| Summary: | summary |