Clearance Summary
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS received FDA 510(k) clearance under submission number K131719, sponsored by Medical Devices (Pvt) , 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 2013-10-30.
- Submission: K131719
- Applicant / Sponsor: Medical Devices (Pvt) , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1570
- Decision date: 2013-10-30
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.