The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Levelert Ii Fluid Level Sensor.
| Device ID | K060123 |
| 510k Number | K060123 |
| Device Name: | LEVELERT II FLUID LEVEL SENSOR |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Janice Haselton |
| Correspondent | Janice Haselton SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-18 |
| Decision Date | 2006-02-14 |
| Summary: | summary |