21 CFR 880.6500 — Purifier, Air, Ultraviolet, Medical
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6500
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FRA | Purifier, Air, Ultraviolet, Medical | 2 | 36 | 3rd Party |
| MKB | Device, Germicidal, Ultraviolet | 2 | 0 | 3rd Party |