FDA 510(k)

Sterile and Non-Sterile Ultrasound Gels

K-번호: K232957 · 2023-12-15

결정일2023-12-15

제품 코드MUI

자문 위원회RA

결정Substantially Equivalent

기기 요약

Sterile and Non-Sterile Ultrasound Gels is the device name listed in this FDA 510(k) record. The listed applicant is Jianerkang Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K232957. 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 Ultrasound Gels?

Sterile and Non-Sterile Ultrasound Gels is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Jianerkang Medical Co., Ltd.. The 510(k) number is K232957.

When did Sterile and Non-Sterile Ultrasound Gels receive FDA 510(k) clearance?

Sterile and Non-Sterile Ultrasound Gels received FDA 510(k) clearance on 2023-12-15, under 510(k) number K232957.

Who is the listed applicant for Sterile and Non-Sterile Ultrasound Gels?

The FDA 510(k) record lists Jianerkang Medical 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 Ultrasound Gels?

The FDA product code for Sterile and Non-Sterile Ultrasound Gels is MUI.

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Sterile and Non-Sterile Ultrasound Gels

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MUI)

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