21 CFR 880.2420 — Monitor, Electric For Gravity Flow Infusion Systems
General Hospital (HO) · Part 880 Subpart C—General Hospital and Personal Use Monitoring Devices · § 880.2420
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 2 | 39 | 3rd Party |
