Cleared Special

RetCam 3 ; RetCam Shuttle ; RetCam Portable

K182263 · Natus Medical Incorporated · Ophthalmic
Sep 2018
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K182263 is an FDA 510(k) clearance for the RetCam 3 ; RetCam Shuttle ; RetCam Portable, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Natus Medical Incorporated (Pleasanton, US). The FDA issued a Cleared decision on September 7, 2018, 17 days after receiving the submission on August 21, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K182263 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2018
Decision Date September 07, 2018
Days to Decision 17 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120