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FDA 510(k)

VS3-IR

K-Number: K183453 · 2019-03-04

ApplicantMedtronic
Decision Date2019-03-04
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VS3-IR is a medical device manufactured by Medtronic. It received FDA 510(k) clearance on 2019-03-04 under approval number K183453. 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 VS3-IR?

VS3-IR is a medical device that received FDA 510(k) clearance on 2019-03-04. It is manufactured by Medtronic. The 510(k) number is K183453.

When was VS3-IR approved by the FDA?

VS3-IR received FDA 510(k) clearance on 2019-03-04, under approval number K183453.

What company makes VS3-IR?

VS3-IR is manufactured by Medtronic.

What is the FDA product code for VS3-IR?

The FDA product code for VS3-IR is OWN.

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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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