HEINE BETA 200(R) OPHTHALMOSCOPE— 510(k) K131961

Name: FDA 510(k) clearance K131961
Creator: U.S. Food and Drug Administration
Published: 2013-12-04

Substantially Equivalent

Heine Optotechnik GmbH & Co. KG

FDA 510(k) clearance K131961 for HEINE BETA 200(R) OPHTHALMOSCOPE, Substantially Equivalent on 2013-12-04. Applicant: Heine Optotechnik GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Heine Optotechnik GmbH & Co. KG
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2013-06-27
Decision date: 2013-12-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Herrsching, DE

Download summary PDF View on FDA.gov ↗

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