Cleared Abbreviated

HEINE MINI 3000(R) OPHTHALMOSCOPE

K131959 · Heine Optotechnik GmbH & Co. KG · Ophthalmic
Mar 2014
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K131959 is an FDA 510(k) clearance for the HEINE MINI 3000(R) OPHTHALMOSCOPE, a Ophthalmoscope, Battery-powered (Class II — Special Controls, product code HLJ), submitted by Heine Optotechnik GmbH & Co. KG (Herrsching, DE). The FDA issued a Cleared decision on March 7, 2014, 253 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 K131959 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2013
Decision Date March 07, 2014
Days to Decision 253 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HLJ — Ophthalmoscope, Battery-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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