Clearance Summary
ZEIMER SELF TONOMETER received FDA 510(k) clearance under submission number K953031, sponsored by Cds Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1995-08-22.
- Submission: K953031
- Applicant / Sponsor: Cds Technologies
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 1995-08-22
Classification & Regulation
This clearance is catalogued under FDA product code HKX and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.