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FDA 510(k)

Medical RF

K-Number: K192621 · 2020-11-06

ApplicantTriworks Group Srl
Decision Date2020-11-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical RF is the device name listed in this FDA 510(k) record. The listed applicant is Triworks Group Srl. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K192621. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical RF?

Medical RF is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Triworks Group Srl. The 510(k) number is K192621.

When did Medical RF receive FDA 510(k) clearance?

Medical RF received FDA 510(k) clearance on 2020-11-06, under 510(k) number K192621.

Who is the listed applicant for Medical RF?

The FDA 510(k) record lists Triworks Group Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical RF?

The FDA product code for Medical RF is GEI.

Other records listing Triworks Group Srl as applicant

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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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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