The following data is part of a premarket notification filed by Philosys Inc. with the FDA for Gmate Origin Blood Glucose Monitoring System.
| Device ID | K151658 |
| 510k Number | K151658 |
| Device Name: | Gmate Origin Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Philosys Inc. 304 PARK AVENUE SOUTH, SUITE 218 New York, NY 10016 |
| Contact | Linda Chan |
| Correspondent | Linda Chan PHILOSYS, INC. 304 PARK AVENUE SOUTH, SUITE 218 New York, NY 10016 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-19 |
| Decision Date | 2015-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809301162217 | K151658 | 000 |
| 08809301162200 | K151658 | 000 |
| 08809301162194 | K151658 | 000 |
| 08809301161777 | K151658 | 000 |
| 08809301160862 | K151658 | 000 |