Clearance Summary
PROJECTOR, ACCU-CHART ACUITY received FDA 510(k) clearance under submission number K781658, sponsored by Bausch & Lomb, 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 1978-10-17.
- Submission: K781658
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1680
- Decision date: 1978-10-17
Classification & Regulation
This clearance is catalogued under FDA product code HOS and 21 CFR 886.1680, within the Ophthalmic review panel as a Class I device.