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FDA 510(k)

iVitri EZ

K-Number: K162640 · 2017-06-30

ApplicantReprobitech Corp.
Decision Date2017-06-30
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

iVitri EZ is a medical device manufactured by Reprobitech Corp.. It received FDA 510(k) clearance on 2017-06-30 under approval number K162640. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iVitri EZ?

iVitri EZ is a medical device that received FDA 510(k) clearance on 2017-06-30. It is manufactured by Reprobitech Corp.. The 510(k) number is K162640.

When was iVitri EZ approved by the FDA?

iVitri EZ received FDA 510(k) clearance on 2017-06-30, under approval number K162640.

What company makes iVitri EZ?

iVitri EZ is manufactured by Reprobitech Corp..

What is the FDA product code for iVitri EZ?

The FDA product code for iVitri EZ is MQK.

Other Devices by Reprobitech Corp.

K172751iVitri Straw

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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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