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FDA 510(k)

ARGOS

K-Number: K061479 · 2007-04-05

Decision Date2007-04-05
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ARGOS is the device name listed in this FDA 510(k) record. The listed applicant is 3D Line Medical Systems S.R.L.. It received FDA 510(k) clearance on 2007-04-05 under 510(k) number K061479. The device is classified under product code HAW. It was reviewed by the NE 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 2007-04-05. The listed applicant is 3D Line Medical Systems S.R.L.. The 510(k) number is K061479.

When did ARGOS receive FDA 510(k) clearance?

ARGOS received FDA 510(k) clearance on 2007-04-05, under 510(k) number K061479.

Who is the listed applicant for ARGOS?

The FDA 510(k) record lists 3D Line Medical Systems S.R.L. 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 HAW.

Related Clinical Trials

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.

Other records listing 3D Line Medical Systems S.R.L. as applicant

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.

Related Devices (Code: HAW)

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.

Official Source

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

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