Clearance Summary
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS received FDA 510(k) clearance under submission number K122432, 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 2012-12-06.
- Submission: K122432
- Applicant / Sponsor: Fisher & Paykel Healthcare, Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5270
- Decision date: 2012-12-06
Classification & Regulation
This clearance is catalogued under FDA product code BZE and 21 CFR 868.5270, within the Anesthesiology review panel as a Class II device.