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FDA 510(k)

visor2 system

K-Number: K210109 · 2022-04-08

ApplicantEemagine Medical Imaging Solutions GmbH
Decision Date2022-04-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

visor2 system is the device name listed in this FDA 510(k) record. The listed applicant is Eemagine Medical Imaging Solutions GmbH. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K210109. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the visor2 system?

visor2 system is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K210109.

When did visor2 system receive FDA 510(k) clearance?

visor2 system received FDA 510(k) clearance on 2022-04-08, under 510(k) number K210109.

Who is the listed applicant for visor2 system?

The FDA 510(k) record lists Eemagine Medical Imaging Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for visor2 system?

The FDA product code for visor2 system is HAW.

Other records listing Eemagine Medical Imaging Solutions GmbH as applicant

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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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