Clearance Summary
OXYCON received FDA 510(k) clearance under submission number K813436, sponsored by Home Medical Mfg., Co., 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 1982-01-07.
- Submission: K813436
- Applicant / Sponsor: Home Medical Mfg., Co., Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1982-01-07
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.