Clearance Summary
ORACLE ORAL MASK received FDA 510(k) clearance under submission number K003894, sponsored by Fisher & Paykel Healthcare, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-06-25.
- Submission: K003894
- Applicant / Sponsor: Fisher & Paykel Healthcare, Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2001-06-25
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.