Cleared Abbreviated

HEINE BETA 200(R) OPHTHALMOSCOPE

K131961 · Heine Optotechnik GmbH & Co. KG · Ophthalmic
Dec 2013
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K131961 is an FDA 510(k) clearance for the HEINE BETA 200(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 December 4, 2013, 160 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 K131961 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2013
Decision Date December 04, 2013
Days to Decision 160 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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