FDA 510(k)

솔리톤 음파 장치

K-번호: K190542 · 2019-05-24

결정일2019-05-24

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

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.

자주 묻는 질문

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.

Soliton, Inc.를 신청인으로 등재한 기타 기록

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