ARGOS— 510(k) K191051

Substantially Equivalent

Santec Corporation

FDA 510(k) clearance K191051 for ARGOS, Substantially Equivalent on 2019-05-16. Applicant: Santec Corporation. Device class: 2.

Clearance details

Applicant: Santec Corporation
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2019-04-19
Decision date: 2019-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Komaki, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.