Clearance Summary
CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD received FDA 510(k) clearance under submission number K861019, sponsored by Phase One Disign Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1986-04-02.
- Submission: K861019
- Applicant / Sponsor: Phase One Disign Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1986-04-02
Classification & Regulation
This clearance is catalogued under FDA product code EAK and 21 CFR 892.6500, within the Radiology review panel as a Class I device.