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FDA 510(k)

Soliton Acoustic Wave Device

K-Number: K190542 · 2019-05-24

ApplicantSoliton, Inc.
Decision Date2019-05-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Soliton Acoustic Wave Device is the device name listed in this FDA 510(k) record. The listed applicant is Soliton, Inc.. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K190542. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soliton Acoustic Wave Device?

Soliton Acoustic Wave Device is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Soliton, Inc.. The 510(k) number is K190542.

When did Soliton Acoustic Wave Device receive FDA 510(k) clearance?

Soliton Acoustic Wave Device received FDA 510(k) clearance on 2019-05-24, under 510(k) number K190542.

Who is the listed applicant for Soliton Acoustic Wave Device?

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

What is the FDA product code for Soliton Acoustic Wave Device?

The FDA product code for Soliton Acoustic Wave Device is GEX. This falls under the Gastroenterology category.

Other records listing Soliton, Inc. 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.

K212502Resonic Rapid Acoustic Pulse DeviceK210964Resonic Rapid Acoustic Pulse DeviceK201801Rapid Acoustic Pulse DeviceK200331Rapid Acoustic Pulse Device

Related Devices (Code: GEX)

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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