The following data is part of a premarket notification filed by Lifescan Europe with the FDA for Onetouch Verio Flex Blood Glucose Monitoring System.
| Device ID | K150214 |
| 510k Number | K150214 |
| Device Name: | OneTouch Verio Flex Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN EUROPE GUBELSTRASSE 34 Zug, CH Ch-6300 |
| Contact | Alison Wilson |
| Correspondent | Alison Wilson LIFESCAN SCOTLAND LTD BEECHWOOD PARK NORTH Inverness, GB Iv2 3ed |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-07-31 |
| Summary: | summary |