510(k) DEN210037
DEN210037 is an FDA 510(k) premarket notification submitted by Soclean, Inc. for the device "SoClean 3+ Bacterial Reduction Device". The FDA issued a decision of De Novo Granted on August 12, 2024. The device falls under product code QXQ (Respiratory Accessory Microbial Reduction Device.), a Class II device regulated under 21 CFR 880.6993. Soclean, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 12, 2024
- Date Received
- September 15, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respiratory Accessory Microbial Reduction Device.
- Device Class
- Class II
- Regulation Number
- 880.6993
- Review Panel
- HO
- Submission Type
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.