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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 a medical device manufactured by Institut Georges Lopez. It received FDA 510(k) clearance on 2021-10-15 under approval 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. It is manufactured by Institut Georges Lopez. The 510(k) number is K211224.

When was RM4 Control Unit approved by the FDA?

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

What company makes RM4 Control Unit?

RM4 Control Unit is manufactured by Institut Georges Lopez.

What is the FDA product code for RM4 Control Unit?

The FDA product code for RM4 Control Unit is KDN.

Other Devices by Institut Georges Lopez

K221386PERF-GEN Pulsatile Perfusion Solution K221387BEL-GEN Cold Storage Solution

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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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