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FDA 510(k)

UniVit HE, UniVit UHS

K-Number: K212763 · 2022-08-10

ApplicantVisioncare Devices, LLC
Decision Date2022-08-10
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UniVit HE, UniVit UHS is the device name listed in this FDA 510(k) record. The listed applicant is Visioncare Devices, LLC. It received FDA 510(k) clearance on 2022-08-10 under 510(k) number K212763. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UniVit HE, UniVit UHS?

UniVit HE, UniVit UHS is a medical device that received FDA 510(k) clearance on 2022-08-10. The listed applicant is Visioncare Devices, LLC. The 510(k) number is K212763.

When did UniVit HE, UniVit UHS receive FDA 510(k) clearance?

UniVit HE, UniVit UHS received FDA 510(k) clearance on 2022-08-10, under 510(k) number K212763.

Who is the listed applicant for UniVit HE, UniVit UHS?

The FDA 510(k) record lists Visioncare Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniVit HE, UniVit UHS?

The FDA product code for UniVit HE, UniVit UHS is HQE.

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Official Source

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