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FDA 510(k)

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

K-Number: K193522 · 2020-08-25

ApplicantKitazato Corporation
Decision Date2020-08-25
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is a medical device manufactured by Kitazato Corporation. It received FDA 510(k) clearance on 2020-08-25 under approval number K193522. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is a medical device that received FDA 510(k) clearance on 2020-08-25. It is manufactured by Kitazato Corporation. The 510(k) number is K193522.

When was iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA approved by the FDA?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA received FDA 510(k) clearance on 2020-08-25, under approval number K193522.

What company makes iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is manufactured by Kitazato Corporation.

What is the FDA product code for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA?

The FDA product code for iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA is MQL.

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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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