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FDA 510(k)

EVTOOL MODEL # V. 1.0

K-Number: K013535 · 2002-01-18

Applicant3D Line USA, Inc.
Decision Date2002-01-18
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EVTOOL MODEL # V. 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is 3D Line USA, Inc.. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K013535. 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 EVTOOL MODEL # V. 1.0?

EVTOOL MODEL # V. 1.0 is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is 3D Line USA, Inc.. The 510(k) number is K013535.

When did EVTOOL MODEL # V. 1.0 receive FDA 510(k) clearance?

EVTOOL MODEL # V. 1.0 received FDA 510(k) clearance on 2002-01-18, under 510(k) number K013535.

Who is the listed applicant for EVTOOL MODEL # V. 1.0?

The FDA 510(k) record lists 3D Line USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVTOOL MODEL # V. 1.0?

The FDA product code for EVTOOL MODEL # V. 1.0 is MUJ.

Related Clinical Trials

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Other records listing 3D Line USA, Inc. 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.

K034051DYNATRAC, COD. 50-1AK031281ERGO SRSK031631STEREOTACTIC BODY FRAME, MODEL COD. 70-1AK0112553D LINE STEROTACTIC HARDWARE ACCESSORIESK001163DMLC IV-ERGO

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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