Cleared Traditional

K132987 - COBRA FUNDUS CAMERA (FDA 510(k) Clearance)

K132987 · C.S.O. S.R.L. · Ophthalmic device

Jul 2014

Decision

282d

Days

Class 2

Risk

K132987 is an FDA 510(k) clearance for the COBRA FUNDUS CAMERA. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II - Special Controls, product code HKI).

Submitted by C.S.O. S.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on July 3, 2014, 282 days after receiving the submission on September 24, 2013.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K132987 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 2013
Decision Date	July 03, 2014
Days to Decision	282 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF