Clearance Summary
ERGO DIAGNOSTIC CARD received FDA 510(k) clearance under submission number K834145, sponsored by American Ergo Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-03-16.
- Submission: K834145
- Applicant / Sponsor: American Ergo Systems
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1150
- Decision date: 1984-03-16
Classification & Regulation
This clearance is catalogued under FDA product code HOX and 21 CFR 886.1150, within the Ophthalmic review panel as a Class I device.