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FDA 510(k)

Soniquence Reusable 3 Button Fingerswitch Wand

K-Number: K212222 · 2022-09-02

Decision Date2022-09-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Soniquence Reusable 3 Button Fingerswitch Wand is a medical device manufactured by Soniquence, LLC. It received FDA 510(k) clearance on 2022-09-02 under approval number K212222. 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 Reusable 3 Button Fingerswitch Wand?

Soniquence Reusable 3 Button Fingerswitch Wand is a medical device that received FDA 510(k) clearance on 2022-09-02. It is manufactured by Soniquence, LLC. The 510(k) number is K212222.

When was Soniquence Reusable 3 Button Fingerswitch Wand approved by the FDA?

Soniquence Reusable 3 Button Fingerswitch Wand received FDA 510(k) clearance on 2022-09-02, under approval number K212222.

What company makes Soniquence Reusable 3 Button Fingerswitch Wand?

Soniquence Reusable 3 Button Fingerswitch Wand is manufactured by Soniquence, LLC.

What is the FDA product code for Soniquence Reusable 3 Button Fingerswitch Wand?

The FDA product code for Soniquence Reusable 3 Button Fingerswitch Wand is GEI.

Other Devices by Soniquence, LLC

Related Devices (Code: GEI)

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.