Clearance Summary
VOROSCOPE(TM) received FDA 510(k) clearance under submission number K871735, sponsored by Australian Biomedical Corporation , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-06-03.
- Submission: K871735
- Applicant / Sponsor: Australian Biomedical Corporation , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 1987-06-03
Classification & Regulation
This clearance is catalogued under FDA product code HLJ and 21 CFR 886.1570, within the Ophthalmic review panel as a Class II device.