Clearance Summary
SPOT RETINOSCOPE RX-3SP received FDA 510(k) clearance under submission number K950793, sponsored by Neitz Instruments Company, 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 1995-03-28.
- Submission: K950793
- Applicant / Sponsor: Neitz Instruments Company, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1780
- Decision date: 1995-03-28
Classification & Regulation
This clearance is catalogued under FDA product code HKM and 21 CFR 886.1780, within the Ophthalmic review panel as a Class I device.