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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 the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2017-01-13 under 510(k) 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. The listed applicant is Cefla S.C.. The 510(k) number is K163519.

When did RX DC receive FDA 510(k) clearance?

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

Who is the listed applicant for RX DC?

The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RX DC?

The FDA product code for RX DC is EHD.

Other records listing Cefla S.C. as applicant

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Related Devices (Code: EHD)

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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