21 CFR 880.6993 — Respiratory Accessory Microbial Reduction Device.
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6993
Identification
A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories, such as hoses and masks, after cleaning. This device is not intended to replace the original accessory manufacturer's cleaning instructions.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated using general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXQ | Respiratory Accessory Microbial Reduction Device. | 2 | 2 | SaMD |
Special Controls
QXQ — Respiratory Accessory Microbial Reduction Device.
In combination with the general controls of the FD&C Act, the respiratory accessory microbial reduction device is subject to the following special controls:
De Novo Order DEN210037
