FDA 510(k)

기타-소닉 전달 젤

K-번호: K163023 · 2018-01-08

결정일2018-01-08

제품 코드MUI

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

결정대체적으로 동일

기기 요약

Other-Sonic Transmission Gel is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaceutical Innovations, Inc.. It received FDA 510(k) clearance on 2018-01-08 under 510(k) number K163023. 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 Other-Sonic Transmission Gel?

Other-Sonic Transmission Gel is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is Pharmaceutical Innovations, Inc.. The 510(k) number is K163023.

When did Other-Sonic Transmission Gel receive FDA 510(k) clearance?

Other-Sonic Transmission Gel received FDA 510(k) clearance on 2018-01-08, under 510(k) number K163023.

Who is the listed applicant for Other-Sonic Transmission Gel?

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

What is the FDA product code for Other-Sonic Transmission Gel?

The FDA product code for Other-Sonic Transmission Gel is MUI.

Pharmaceutical Innovations, Inc.를 신청인으로 등재한 기타 기록

K163027우ltrasonic/Phonic 자유 전도성 젤 K163026유트라/폰릭 스캔 젤 K163024유트라/폰릭 전도성 젤

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