Clearance Summary
TANDEM SCANNING MICROSCOPE received FDA 510(k) clearance under submission number K912514, sponsored by Tandem Scanning Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1991-12-16.
- Submission: K912514
- Applicant / Sponsor: Tandem Scanning Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 1991-12-16
Classification & Regulation
This clearance is catalogued under FDA product code HJO and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.