DEN210037 is an FDA 510(k) submission for the SoClean 3+ Bacterial Reduction Device. This device is classified as a Respiratory Accessory Microbial Reduction Device. (Class II - Special Controls, product code QXQ).
Submitted by Soclean, Inc. (Peterborough, US). The FDA issued a Not Cleared (DENG) decision on August 12, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6993. 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 Manufacturers Cleaning Instructions..
| 510(k) Number | DEN210037 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 15, 2021 |
| Decision Date | August 12, 2024 |
| Days to Decision | 1062 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | QXQ - Respiratory Accessory Microbial Reduction Device. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6993 |
| Definition | 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 Manufacturers Cleaning Instructions. |