The following data is part of a premarket notification filed by Roche Diabetes Care Inc. with the FDA for Iwl2020 Blood Glucose Monitoring System.
| Device ID | K203711 |
| 510k Number | K203711 |
| Device Name: | IWL2020 Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diabetes Care Inc. 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Contact | Kelly Brennan |
| Correspondent | Kelly Brennan Roche Diabetes Care Inc. 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50681131403288 | K203711 | 000 |
| 00681131403276 | K203711 | 000 |