Clearance Summary
MACOM received FDA 510(k) clearance under submission number K973148, sponsored by A.Stein - Regulatory Affairs Consulting. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-11-20.
- Submission: K973148
- Applicant / Sponsor: A.Stein - Regulatory Affairs Consulting
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 1997-11-20
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.