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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Terumo Clinical Supply Co., Ltd.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) 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. The listed applicant is Terumo Clinical Supply Co., Ltd.. The 510(k) number is K211078.

When did Progreat Lambda receive FDA 510(k) clearance?

Progreat Lambda received FDA 510(k) clearance on 2021-12-21, under 510(k) number K211078.

Who is the listed applicant for Progreat Lambda?

The FDA 510(k) record lists Terumo Clinical Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Progreat Lambda?

The FDA product code for Progreat Lambda is DQO.

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Related Devices (Code: DQO)

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.

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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.

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