FDA 510(k)

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes

K-Number: K183640 · 2019-02-22

Decision Date2019-02-22

Product CodeOWN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Cellvizio 100 Series Confocal laser Imaging systems and their 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 2019-02-22 under 510(k) number K183640. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes?

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Mauna Kea Technologies. The 510(k) number is K183640.

When did Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes receive FDA 510(k) clearance?

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes received FDA 510(k) clearance on 2019-02-22, under 510(k) number K183640.

Who is the listed applicant for Cellvizio 100 Series Confocal laser Imaging systems and their 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 Confocal laser Imaging systems and their Confocal Miniprobes?

The FDA product code for Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is OWN.

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Other records listing Mauna Kea Technologies as applicant

K220477Cellvizio 100 series system with confocal Miniprobes K212322Cellvizio I.V.E. system with Confocal Miniprobes K193416Cellvizio I.V.E. with Confocal Miniprobes K191144Cellvizio 100 Series System with Confocal Miniprobes K180270Cellvizio 100 Series Systems with Confocal Miniprobes K172844Cellvizio 100 Series System with Confocal Miniprobes

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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.