Clearance Summary
P.R.M. 80 received FDA 510(k) clearance under submission number K810590, sponsored by T.E.M. Instruments , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1981-04-10.
- Submission: K810590
- Applicant / Sponsor: T.E.M. Instruments , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1610
- Decision date: 1981-04-10
Classification & Regulation
This clearance is catalogued under FDA product code IZW and 21 CFR 892.1610, within the Radiology review panel as a Class II device.