BEL-GEN Cold Storage Solution
K-Number: K221387 · 2022-06-14
ApplicantInstitut Georges Lopez
Decision Date2022-06-14
Product CodeKDL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BEL-GEN Cold Storage Solution is a medical device manufactured by Institut Georges Lopez. It received FDA 510(k) clearance on 2022-06-14 under approval number K221387. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BEL-GEN Cold Storage Solution?
BEL-GEN Cold Storage Solution is a medical device that received FDA 510(k) clearance on 2022-06-14. It is manufactured by Institut Georges Lopez. The 510(k) number is K221387.
When was BEL-GEN Cold Storage Solution approved by the FDA?
BEL-GEN Cold Storage Solution received FDA 510(k) clearance on 2022-06-14, under approval number K221387.
What company makes BEL-GEN Cold Storage Solution?
BEL-GEN Cold Storage Solution is manufactured by Institut Georges Lopez.
What is the FDA product code for BEL-GEN Cold Storage Solution?
The FDA product code for BEL-GEN Cold Storage Solution is KDL.
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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.