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FDA 510(k)

RiX70 DC

K-Number: K182206 · 2018-09-13

ApplicantTrident S.R.L
Decision Date2018-09-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RiX70 DC is the device name listed in this FDA 510(k) record. The listed applicant is Trident S.R.L. It received FDA 510(k) clearance on 2018-09-13 under 510(k) number K182206. 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 RiX70 DC?

RiX70 DC is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Trident S.R.L. The 510(k) number is K182206.

When did RiX70 DC receive FDA 510(k) clearance?

RiX70 DC received FDA 510(k) clearance on 2018-09-13, under 510(k) number K182206.

Who is the listed applicant for RiX70 DC?

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

What is the FDA product code for RiX70 DC?

The FDA product code for RiX70 DC is EHD.

Other records listing Trident S.R.L 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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