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FDA 510(k)

Soniquence RF Generator and Soniquence Electrodes

K-Number: K183611 · 2019-05-22

ApplicantSoniquence, LLC
Decision Date2019-05-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Soniquence RF Generator and Soniquence Electrodes is a medical device manufactured by Soniquence, LLC. It received FDA 510(k) clearance on 2019-05-22 under approval 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. It is manufactured by Soniquence, LLC. The 510(k) number is K183611.

When was Soniquence RF Generator and Soniquence Electrodes approved by the FDA?

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

What company makes Soniquence RF Generator and Soniquence Electrodes?

Soniquence RF Generator and Soniquence Electrodes is manufactured by Soniquence, LLC.

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.

Related Clinical Trials

NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_RECRUITING

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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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