HEINE SIGMA 250 & HEINE SIGMA 250 M2— 510(k) K142837

Name: FDA 510(k) clearance K142837
Creator: U.S. Food and Drug Administration
Published: 2015-01-29

Substantially Equivalent

Heine Optotechnik GmbH & Co. KG

FDA 510(k) clearance K142837 for HEINE SIGMA 250 & HEINE SIGMA 250 M2, Substantially Equivalent on 2015-01-29. 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: 2014-09-30
Decision date: 2015-01-29
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Herrsching, DE

Download summary PDF View on FDA.gov ↗

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