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 a medical device manufactured by Visioncare Devices, LLC. It received FDA 510(k) clearance on 2022-08-10 under approval 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. It is manufactured by Visioncare Devices, LLC. The 510(k) number is K212763.
When was UniVit HE, UniVit UHS approved by the FDA?
UniVit HE, UniVit UHS received FDA 510(k) clearance on 2022-08-10, under approval number K212763.
What company makes UniVit HE, UniVit UHS?
UniVit HE, UniVit UHS is manufactured by Visioncare Devices, LLC.
What is the FDA product code for UniVit HE, UniVit UHS?
The FDA product code for UniVit HE, UniVit UHS is HQE.
Related Devices (Code: HQE)
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.