Progreat Lambda
K-Number: K211078 · 2021-12-21
ApplicantTerumo Clinical Supply Co., Ltd.
Decision Date2021-12-21
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Progreat Lambda is a medical device manufactured by Terumo Clinical Supply Co., Ltd.. It received FDA 510(k) clearance on 2021-12-21 under approval number K211078. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Progreat Lambda?
Progreat Lambda is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Terumo Clinical Supply Co., Ltd.. The 510(k) number is K211078.
When was Progreat Lambda approved by the FDA?
Progreat Lambda received FDA 510(k) clearance on 2021-12-21, under approval number K211078.
What company makes Progreat Lambda?
Progreat Lambda is manufactured by Terumo Clinical Supply Co., Ltd..
What is the FDA product code for Progreat Lambda?
The FDA product code for Progreat Lambda is DQO.
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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.