510(k) clearance
Altis Full Face Mask
- 510(k) number
- K261262
- Applicant
- Respironics, Inc.
- Decision date
- Sep 25, 2026
- Date received
- Apr 16, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- BZD
- Device type
- Ventilator, Non-Continuous (Respirator)
- Device class
- Class II
- Regulation
- 21 CFR 868.5905
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Murrysville, PA, US