Clearance Summary
ROYAL 1 OXYGEN CONCENTRATOR received FDA 510(k) clearance under submission number K822301, sponsored by Proto-Med, 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 1982-08-19.
- Submission: K822301
- Applicant / Sponsor: Proto-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1982-08-19
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.