Clearance Summary
MAKLAKOV STYLE TONOMETER received FDA 510(k) clearance under submission number K860330, sponsored by Med-Tech Develoment Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1986-02-12.
- Submission: K860330
- Applicant / Sponsor: Med-Tech Develoment Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 1986-02-12
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.