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FDA 510(k)

RM4 Control Unit

K-Number: K211224 · 2021-10-15

ApplicantInstitut Georges Lopez
Decision Date2021-10-15
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RM4 Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Institut Georges Lopez. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K211224. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RM4 Control Unit?

RM4 Control Unit is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Institut Georges Lopez. The 510(k) number is K211224.

When did RM4 Control Unit receive FDA 510(k) clearance?

RM4 Control Unit received FDA 510(k) clearance on 2021-10-15, under 510(k) number K211224.

Who is the listed applicant for RM4 Control Unit?

The FDA 510(k) record lists Institut Georges Lopez as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RM4 Control Unit?

The FDA product code for RM4 Control Unit is KDN.

Other records listing Institut Georges Lopez 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.

K221387BEL-GEN Cold Storage SolutionK221386PERF-GEN Pulsatile Perfusion Solution

Related Devices (Code: KDN)

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.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

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.

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