FDA 510(k)

Vave Wireless Ultrasound System

K-번호: K241051 · 2024-08-30

결정일2024-08-30

제품 코드IYN

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

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기기 요약

Vave Wireless Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Vave Health, Inc.. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K241051. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Vave Wireless Ultrasound System?

Vave Wireless Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Vave Health, Inc.. The 510(k) number is K241051.

When did Vave Wireless Ultrasound System receive FDA 510(k) clearance?

Vave Wireless Ultrasound System received FDA 510(k) clearance on 2024-08-30, under 510(k) number K241051.

Who is the listed applicant for Vave Wireless Ultrasound System?

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

What is the FDA product code for Vave Wireless Ultrasound System?

The FDA product code for Vave Wireless Ultrasound System is IYN.

Vave Health, Inc.를 신청인으로 등재한 기타 기록

K191541Vave Personal Ultrasound System

관련 기기 (코드: IYN)

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