Cleared Traditional

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS

K131719 · Medical Devices (Pvt) , Ltd. · Ophthalmic

Oct 2013

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K131719 is an FDA 510(k) clearance for the OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS, a Ophthalmoscope, Battery-powered (Class II — Special Controls, product code HLJ), submitted by Medical Devices (Pvt) , Ltd. (Ugoki-Sialkot, PK). The FDA issued a Cleared decision on October 30, 2013, 140 days after receiving the submission on June 12, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K131719 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2013
Decision Date	October 30, 2013
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement