Clearance Summary
INTELLISAVE AX700 ANESTHESIA SYSTEM received FDA 510(k) clearance under submission number K122063, sponsored by Philips Anesthesia Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-08-02.
- Submission: K122063
- Applicant / Sponsor: Philips Anesthesia Care
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2013-08-02
Classification & Regulation
This clearance is catalogued under FDA product code BSZ and 21 CFR 868.5160, within the Anesthesiology review panel as a Class II device.