510(k) K252471
- Device
- Paptizer 360
- Applicant
- LiViliti Health Products Corporation
- 510(k) number
- K252471
- Product code
- QXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-29
- Date received
- 2025-08-06
- 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
Applicant Contact#
- Contact
- Brian Sharpe
- Address
- 2140 SW Main Blvd. Lake City FL US 32025 32025
FDA Registration Numbers#
- 3003927385
- 3009534409