I.V. SENTINEL
Device Facts
| Record ID | K821823 |
|---|---|
| Device Name | I.V. SENTINEL |
| Applicant | The John Bunn Co. |
| Product Code | FLN · General Hospital |
| Decision Date | Aug 16, 1982 |
| 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.