Clearance Summary
MODEL 200 received FDA 510(k) clearance under submission number K830468, sponsored by Western Laboratories 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 1983-04-12.
- Submission: K830468
- Applicant / Sponsor: Western Laboratories Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4445
- Decision date: 1983-04-12
Classification & Regulation
This clearance is catalogued under FDA product code FTZ and 21 CFR 886.4445, within the Ophthalmic review panel as a Class I device.