Cleared Abbreviated

HEINE BETA 200, HEINE BETA 200 S, HEINE K 180

K142486 · Heine Optotechnik GmbH & Co. KG · Ophthalmic
May 2015
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K142486 is an FDA 510(k) clearance for the HEINE BETA 200, HEINE BETA 200 S, HEINE K 180, 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 May 18, 2015, 256 days after receiving the submission on September 4, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K142486 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2014
Decision Date May 18, 2015
Days to Decision 256 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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