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FDA 510(k)

3VISEON

K-Number: K043097 · 2004-11-19

Applicant3Mensio Medical Imaging BV
Decision Date2004-11-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3VISEON is the device name listed in this FDA 510(k) record. The listed applicant is 3Mensio Medical Imaging BV. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K043097. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3VISEON?

3VISEON is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is 3Mensio Medical Imaging BV. The 510(k) number is K043097.

When did 3VISEON receive FDA 510(k) clearance?

3VISEON received FDA 510(k) clearance on 2004-11-19, under 510(k) number K043097.

Who is the listed applicant for 3VISEON?

The FDA 510(k) record lists 3Mensio Medical Imaging BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3VISEON?

The FDA product code for 3VISEON is LLZ.

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 3Mensio Medical Imaging BV 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.

K0726533VISEON/SURGERY

Related Devices (Code: LLZ)

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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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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