The following data is part of a premarket notification filed by Entra Health Systems, Ltd. with the FDA for Myglucohealth Glucose Monitoring Systems.
| Device ID | K081703 |
| 510k Number | K081703 |
| Device Name: | MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ENTRA HEALTH SYSTEMS, LTD. 7833 KNOLLBROOK DRIVE Pleasanton, CA 94588 |
| Contact | Carlos Gonzalez |
| Correspondent | Carlos Gonzalez ENTRA HEALTH SYSTEMS, LTD. 7833 KNOLLBROOK DRIVE Pleasanton, CA 94588 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2009-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852668007095 | K081703 | 000 |
| 00850081003007 | K081703 | 000 |