Cruxcan (CRX-1000)
K-Number: K183637 · 2019-02-12
ApplicantCruxell Corp.
Decision Date2019-02-12
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Cruxcan (CRX-1000) is a medical device manufactured by Cruxell Corp.. It received FDA 510(k) clearance on 2019-02-12 under approval number K183637. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cruxcan (CRX-1000)?
Cruxcan (CRX-1000) is a medical device that received FDA 510(k) clearance on 2019-02-12. It is manufactured by Cruxell Corp.. The 510(k) number is K183637.
When was Cruxcan (CRX-1000) approved by the FDA?
Cruxcan (CRX-1000) received FDA 510(k) clearance on 2019-02-12, under approval number K183637.
What company makes Cruxcan (CRX-1000)?
Cruxcan (CRX-1000) is manufactured by Cruxell Corp..
What is the FDA product code for Cruxcan (CRX-1000)?
The FDA product code for Cruxcan (CRX-1000) is MUH.
Other Devices by Cruxell Corp.
Related Devices (Code: MUH)
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.