510(k) K243815
- Device
- SoClean 3+
- Applicant
- Soclean, Inc.
- 510(k) number
- K243815
- Product code
- QXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-10
- Date received
- 2024-12-11
- Regulation
- 880.6993
- Classification name
- Respiratory Accessory Microbial Reduction Device.
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- George Peters
- Address
- 1 Vose Farm Rd. Peterborough NH US 03458 03458
FDA Registration Numbers
- 3003927385
- 3009534409