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FDA 510(k)

Cellvizio 100 Series Systems with Confocal Miniprobes

K-Number: K180270 · 2018-05-22

ApplicantMauna Kea Technologies
Decision Date2018-05-22
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cellvizio 100 Series Systems with Confocal Miniprobes is the device name listed in this FDA 510(k) record. The listed applicant is Mauna Kea Technologies. It received FDA 510(k) clearance on 2018-05-22 under 510(k) number K180270. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cellvizio 100 Series Systems with Confocal Miniprobes?

Cellvizio 100 Series Systems with Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2018-05-22. The listed applicant is Mauna Kea Technologies. The 510(k) number is K180270.

When did Cellvizio 100 Series Systems with Confocal Miniprobes receive FDA 510(k) clearance?

Cellvizio 100 Series Systems with Confocal Miniprobes received FDA 510(k) clearance on 2018-05-22, under 510(k) number K180270.

Who is the listed applicant for Cellvizio 100 Series Systems with Confocal Miniprobes?

The FDA 510(k) record lists Mauna Kea Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cellvizio 100 Series Systems with Confocal Miniprobes?

The FDA product code for Cellvizio 100 Series Systems with Confocal Miniprobes is GWG.

Other records listing Mauna Kea Technologies 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.

K220477Cellvizio 100 series system with confocal MiniprobesK212322Cellvizio I.V.E. system with Confocal MiniprobesK193416Cellvizio I.V.E. with Confocal MiniprobesK191144Cellvizio 100 Series System with Confocal MiniprobesK183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesK172844Cellvizio 100 Series System with Confocal Miniprobes

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Related Devices (Code: GWG)

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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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