Clearance Summary
INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM received FDA 510(k) clearance under submission number K003472, sponsored by Sequal Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-06-04.
- Submission: K003472
- Applicant / Sponsor: Sequal Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2001-06-04
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.