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FDA 510(k)

RX DC

K-Number: K163519 · 2017-01-13

ApplicantCefla S.C.
Decision Date2017-01-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RX DC is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2017-01-13 under approval number K163519. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX DC?

RX DC is a medical device that received FDA 510(k) clearance on 2017-01-13. It is manufactured by Cefla S.C.. The 510(k) number is K163519.

When was RX DC approved by the FDA?

RX DC received FDA 510(k) clearance on 2017-01-13, under approval number K163519.

What company makes RX DC?

RX DC is manufactured by Cefla S.C..

What is the FDA product code for RX DC?

The FDA product code for RX DC is EHD.

Other Devices by Cefla S.C.

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Related Devices (Code: EHD)

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.