The following data is part of a premarket notification filed by Entra Health Systems with the FDA for Myglucohealth Wireless System.
| Device ID | K143169 |
| 510k Number | K143169 |
| Device Name: | MyGlucoHealth Wireless System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ENTRA HEALTH SYSTEMS 3111 Camino Del Rio North Suite 101 San Diego, CA 92108 |
| Contact | Richard Strobridge |
| Correspondent | Richa Padhya ENTRA HEALTH SYSTEMS 3111 Camino Del Rio North Suite 101 San Diego, CA 92108 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-04 |
| Decision Date | 2016-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852668007057 | K143169 | 000 |
| 00852668007040 | K143169 | 000 |