Clearance Summary
Applanation Tonometer received FDA 510(k) clearance under submission number K142263, sponsored by Shanghai Mediworks Precision Instruments 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 2016-04-15.
- Submission: K142263
- Applicant / Sponsor: Shanghai Mediworks Precision Instruments Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2016-04-15
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.