Clearance Summary
ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) received FDA 510(k) clearance under submission number K873914, sponsored by Richmond Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-12-11.
- Submission: K873914
- Applicant / Sponsor: Richmond Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1290
- Decision date: 1987-12-11
Classification & Regulation
This clearance is catalogued under FDA product code HPL and 21 CFR 886.1290, within the Ophthalmic review panel as a Class I device.