FDA 510(k)

Soniquence RF Generator and Soniquence Electrodes

K-Number: K183611 · 2019-05-22

Decision Date2019-05-22

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Soniquence RF Generator and Soniquence Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Soniquence, LLC. It received FDA 510(k) clearance on 2019-05-22 under 510(k) number K183611. 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 Soniquence RF Generator and Soniquence Electrodes?

Soniquence RF Generator and Soniquence Electrodes is a medical device that received FDA 510(k) clearance on 2019-05-22. The listed applicant is Soniquence, LLC. The 510(k) number is K183611.

When did Soniquence RF Generator and Soniquence Electrodes receive FDA 510(k) clearance?

Soniquence RF Generator and Soniquence Electrodes received FDA 510(k) clearance on 2019-05-22, under 510(k) number K183611.

Who is the listed applicant for Soniquence RF Generator and Soniquence Electrodes?

The FDA 510(k) record lists Soniquence, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Soniquence RF Generator and Soniquence Electrodes?

The FDA product code for Soniquence RF Generator and Soniquence Electrodes is GEI.

Other records listing Soniquence, LLC 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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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.