Clearance Summary
APEX MEDICAL XT AUTO CPAP 9S-005200 received FDA 510(k) clearance under submission number K083656, sponsored by Apex Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2009-04-22.
- Submission: K083656
- Applicant / Sponsor: Apex Medical Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2009-04-22
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.