The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Smith & Nephew Dyonics Levelert System.
| Device ID | K903193 |
| 510k Number | K903193 |
| Device Name: | SMITH & NEPHEW DYONICS LEVELERT SYSTEM |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Eric Bannon |
| Correspondent | Eric Bannon SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-19 |
| Decision Date | 1990-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556561423 | K903193 | 000 |
| 03596010121202 | K903193 | 000 |
| 03596010121196 | K903193 | 000 |
| 03596010121233 | K903193 | 000 |