Clearance Summary
HUMIDIFIER & ACCESSORIES received FDA 510(k) clearance under submission number K953949, sponsored by Fisher & Paykel Electronics , 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 1995-10-16.
- Submission: K953949
- Applicant / Sponsor: Fisher & Paykel Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1995-10-16
Classification & Regulation
This clearance is catalogued under FDA product code CAW and 21 CFR 868.5440, within the Anesthesiology review panel as a Class II device.