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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 a medical device manufactured by Santec Corporation. It received FDA 510(k) clearance on 2019-05-16 under approval 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. It is manufactured by Santec Corporation. The 510(k) number is K191051.

When was ARGOS approved by the FDA?

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

What company makes ARGOS?

ARGOS is manufactured by Santec Corporation.

What is the FDA product code for ARGOS?

The FDA product code for ARGOS is MXK.

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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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