Clearance Summary
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 received FDA 510(k) clearance under submission number K191137, sponsored by Jvckenwood Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-07-02.
- Submission: K191137
- Applicant / Sponsor: Jvckenwood Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2019-07-02
Classification & Regulation
This clearance is catalogued under FDA product code PGY and 21 CFR 892.2050, within the Radiology review panel as a Class II device.