FDA 510(k)

정화된 및 비정화된 용액 용-ultrasonic couplant

K-번호: K242167 · 2024-09-19

신청자Anhui Deepblue Medical Technology Co., Ltd.

결정일2024-09-19

제품 코드MUI

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

결정대체적으로 동일

기기 요약

Sterile and Non-Sterile Ultrasonic Coupling Agent is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Deepblue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-09-19 under 510(k) number K242167. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sterile and Non-Sterile Ultrasonic Coupling Agent?

Sterile and Non-Sterile Ultrasonic Coupling Agent is a medical device that received FDA 510(k) clearance on 2024-09-19. The listed applicant is Anhui Deepblue Medical Technology Co., Ltd.. The 510(k) number is K242167.

When did Sterile and Non-Sterile Ultrasonic Coupling Agent receive FDA 510(k) clearance?

Sterile and Non-Sterile Ultrasonic Coupling Agent received FDA 510(k) clearance on 2024-09-19, under 510(k) number K242167.

Who is the listed applicant for Sterile and Non-Sterile Ultrasonic Coupling Agent?

The FDA 510(k) record lists Anhui Deepblue Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile and Non-Sterile Ultrasonic Coupling Agent?

The FDA product code for Sterile and Non-Sterile Ultrasonic Coupling Agent is MUI.

Anhui Deepblue Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K240242HCG 가정용 임신 검사 스틱(분말금), HCG 가정용 임신 검사 캐셋(분말금), HCG 가정용 임신 검사 미드스트리밍(분말금)

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