Cleared Abbreviated

HEINE SIGMA 250 & HEINE SIGMA 250 M2

K142837 · Heine Optotechnik GmbH & Co. KG · Ophthalmic
Jan 2015
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K142837 is an FDA 510(k) clearance for the HEINE SIGMA 250 & HEINE SIGMA 250 M2, 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 January 29, 2015, 121 days after receiving the submission on September 30, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K142837 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2014
Decision Date January 29, 2015
Days to Decision 121 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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