The following data is part of a premarket notification filed by Lifescan Europe Gmbh with the FDA for Onetouch Verio Reflect Blood Glucose Monitoring System.
| Device ID | K193475 |
| 510k Number | K193475 |
| Device Name: | OneTouch Verio Reflect Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LifeScan Europe GmbH Gubelstrasse 34 Zug, CH Ch-6300 |
| Contact | Niki Skelly |
| Correspondent | Niki Skelly LifeScan Scotland Ltd. Beechwood Park North Inverness, GB Iv1 3ed |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20353885011727 | K193475 | 000 |
| 20353885011710 | K193475 | 000 |
| 20353885011703 | K193475 | 000 |
| 20353885011697 | K193475 | 000 |
| 20353885012434 | K193475 | 000 |
| 20353885012472 | K193475 | 000 |