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 a medical device manufactured by Cellumed Co., Ltd.. It received FDA 510(k) clearance on 2018-04-11 under approval 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. It is manufactured by Cellumed Co., Ltd.. The 510(k) number is K180121.
When was Rafugen DBM approved by the FDA?
Rafugen DBM received FDA 510(k) clearance on 2018-04-11, under approval number K180121.
What company makes Rafugen DBM?
Rafugen DBM is manufactured by Cellumed Co., Ltd..
What is the FDA product code for Rafugen DBM?
The FDA product code for Rafugen DBM is MQV.
Related Devices (Code: MQV)
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.