K233555
- 510(k) number
- K233555
- Device name
- AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
- Applicant
- Philips Respironics PA · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-07-31
- Date received
- 2023-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K233555.pdf
Official FDA record: K233555
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.