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FDA 510(k)

Rafugen DBM

K-Number: K180121 · 2018-04-11

ApplicantCellumed Co., Ltd.
Decision Date2018-04-11
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Rafugen DBM is the device name listed in this FDA 510(k) record. The listed applicant is Cellumed Co., Ltd.. It received FDA 510(k) clearance on 2018-04-11 under 510(k) number K180121. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rafugen DBM?

Rafugen DBM is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Cellumed Co., Ltd.. The 510(k) number is K180121.

When did Rafugen DBM receive FDA 510(k) clearance?

Rafugen DBM received FDA 510(k) clearance on 2018-04-11, under 510(k) number K180121.

Who is the listed applicant for Rafugen DBM?

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

What is the FDA product code for Rafugen DBM?

The FDA product code for Rafugen DBM is MQV.

Related Devices (Code: MQV)

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

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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