510(k) DEN250012
- Device
- LifeVac
- Applicant
- Lifevac, LLC
- 510(k) number
- DEN250012
- Product code
- QXN
- Decision
- Unknown (DENG)
- Decision date
- 2026-03-04
- Date received
- 2025-04-11
- Regulation
- 874.5400
- Classification name
- Suction Anti-Choking Device As A Second-Line Treatment
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Arthur Lih
- Address
- 110 Lake Ave. S., Suite 35 Nesconset NY US 11767 11767
FDA Registration Numbers#
- 3011053282
Source Documents#
510(k) summary PDF not indicated by FDA