FDA 510(k)

MCB UNIT Model: V10GMCBUS

K-Number: K222542 · 2022-09-21

Decision Date2022-09-21

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MCB UNIT Model: V10GMCBUS is the device name listed in this FDA 510(k) record. The listed applicant is Lamidey Noury Medical. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K222542. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MCB UNIT Model: V10GMCBUS?

MCB UNIT Model: V10GMCBUS is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Lamidey Noury Medical. The 510(k) number is K222542.

When did MCB UNIT Model: V10GMCBUS receive FDA 510(k) clearance?

MCB UNIT Model: V10GMCBUS received FDA 510(k) clearance on 2022-09-21, under 510(k) number K222542.

Who is the listed applicant for MCB UNIT Model: V10GMCBUS?

The FDA 510(k) record lists Lamidey Noury Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MCB UNIT Model: V10GMCBUS?

The FDA product code for MCB UNIT Model: V10GMCBUS is KNS.

Other records listing Lamidey Noury Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240504PLASMA EDGE System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.