MKB · Device, Germicidal, Ultraviolet
General Hospital · 21 CFR 880.6500 · Class 2
Overview
| Product Code | MKB |
|---|---|
| Device Name | Device, Germicidal, Ultraviolet |
| Regulation | 21 CFR 880.6500 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
