Clearance Summary
OPTIMAX/ COMPACT 2 received FDA 510(k) clearance under submission number K992818, sponsored by Protec GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-09-01.
- Submission: K992818
- Applicant / Sponsor: Protec GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1999-09-01
Classification & Regulation
This clearance is catalogued under FDA product code IXW and 21 CFR 892.1900, within the Radiology review panel as a Class II device.