Clearance Summary
Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q received FDA 510(k) clearance under submission number K191314, sponsored by Chongqing Sunkingdom Medical Instrument Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2019-12-19.
- Submission: K191314
- Applicant / Sponsor: Chongqing Sunkingdom Medical Instrument Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2019-12-19
Classification & Regulation
This clearance is catalogued under FDA product code HKY and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.