Cleared Traditional

AMICO DH-W35 OPHTHALMOSCOPE SERIES

K131939 · Amico Diagnostic Incorporated · Ophthalmic

Mar 2014

Decision

272d

Days

Class 2

Risk

About This 510(k) Submission

K131939 is an FDA 510(k) clearance for the AMICO DH-W35 OPHTHALMOSCOPE SERIES, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Amico Diagnostic Incorporated (Apollo Beach, US). The FDA issued a Cleared decision on March 26, 2014, 272 days after receiving the submission on June 27, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K131939 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2013
Decision Date	March 26, 2014
Days to Decision	272 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF