SMITH & NEPHEW DYONICS LEVELERT SYSTEM
Device Facts
| Record ID | K903193 |
|---|---|
| Device Name | SMITH & NEPHEW DYONICS LEVELERT SYSTEM |
| Applicant | Smith & Nephew Dyonics, Inc. |
| Product Code | FLN · General Hospital |
| Decision Date | Aug 30, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2420 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.