Clearance Summary
ACCUMAP AUTOMATIC PERIMETER received FDA 510(k) clearance under submission number K022304, sponsored by Objectivision Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-11-14.
- Submission: K022304
- Applicant / Sponsor: Objectivision Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1890
- Decision date: 2003-11-14
Classification & Regulation
This clearance is catalogued under FDA product code GWE and 21 CFR 882.1890, within the Neurology review panel as a Class II device.