Clearance Summary
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM received FDA 510(k) clearance under submission number K031831, sponsored by Topcon Medical Systems, 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 2003-12-19.
- Submission: K031831
- Applicant / Sponsor: Topcon Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1760
- Decision date: 2003-12-19
Classification & Regulation
This clearance is catalogued under FDA product code HKO and 21 CFR 886.1760, within the Ophthalmic review panel as a Class I device.