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FDA 510(k)

ARGOS

K-Number: K191051 · 2019-05-16

ApplicantSantec Corporation
Decision Date2019-05-16
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ARGOS is the device name listed in this FDA 510(k) record. The listed applicant is Santec Corporation. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K191051. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGOS?

ARGOS is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Santec Corporation. The 510(k) number is K191051.

When did ARGOS receive FDA 510(k) clearance?

ARGOS received FDA 510(k) clearance on 2019-05-16, under 510(k) number K191051.

Who is the listed applicant for ARGOS?

The FDA 510(k) record lists Santec Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGOS?

The FDA product code for ARGOS is MXK.

Related Devices (Code: MXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey CorporationK223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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