Clearance Summary
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS received FDA 510(k) clearance under submission number K093495, sponsored by American Diagnostic 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 2010-11-19.
- Submission: K093495
- Applicant / Sponsor: American Diagnostic Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2010-11-19
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.