Clearance Summary
PERLINK SCREEN, KIRAN SCREEN received FDA 510(k) clearance under submission number K896707, sponsored by Perlink USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-08-30.
- Submission: K896707
- Applicant / Sponsor: Perlink USA, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1960
- Decision date: 1990-08-30
Classification & Regulation
This clearance is catalogued under FDA product code EAM and 21 CFR 892.1960, within the Radiology review panel as a Class I device.