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FDA 510(k)

ERGO++ VERSION 1.7

K-Number: K080601 · 2008-06-06

Applicant3D Line Medical Systems S.R.L.
Decision Date2008-06-06
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ERGO++ VERSION 1.7 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 2008-06-06 under 510(k) number K080601. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGO++ VERSION 1.7?

ERGO++ VERSION 1.7 is a medical device that received FDA 510(k) clearance on 2008-06-06. The listed applicant is 3D Line Medical Systems S.R.L.. The 510(k) number is K080601.

When did ERGO++ VERSION 1.7 receive FDA 510(k) clearance?

ERGO++ VERSION 1.7 received FDA 510(k) clearance on 2008-06-06, under 510(k) number K080601.

Who is the listed applicant for ERGO++ VERSION 1.7?

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 ERGO++ VERSION 1.7?

The FDA product code for ERGO++ VERSION 1.7 is MUJ.

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.

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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.

K061479ARGOS

Related Devices (Code: MUJ)

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

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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