Clearance Summary
OXYGEN CONCENTRATOR received FDA 510(k) clearance under submission number K781300, sponsored by Bendix Instruments & Life Support Div. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1978-10-16.
- Submission: K781300
- Applicant / Sponsor: Bendix Instruments & Life Support Div
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1978-10-16
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.