Clearance Summary
PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) received FDA 510(k) clearance under submission number K022684, sponsored by Essex Cryogenics of Missouri, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2002-09-11.
- Submission: K022684
- Applicant / Sponsor: Essex Cryogenics of Missouri, Inc.
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2002-09-11
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.