Clearance Summary
HEAD HOLDING DEVICE/SLEEP APNEA received FDA 510(k) clearance under submission number K884493, sponsored by X-Ray Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1989-01-12.
- Submission: K884493
- Applicant / Sponsor: X-Ray Systems
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1920
- Decision date: 1989-01-12
Classification & Regulation
This clearance is catalogued under FDA product code IWY and 21 CFR 892.1920, within the Radiology review panel as a Class I device.