FDA 510(k)

우ltrasonic/Phonic 자유 전도성 젤

K-번호: K163027 · 2018-01-09

결정일2018-01-09

제품 코드MUI

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

결정대체적으로 동일

기기 요약

Ultra/Phonic Free Conductivity 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 2018-01-09 under 510(k) number K163027. 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 Ultra/Phonic Free Conductivity Gel?

Ultra/Phonic Free Conductivity Gel is a medical device that received FDA 510(k) clearance on 2018-01-09. The listed applicant is Pharmaceutical Innovations, Inc.. The 510(k) number is K163027.

When did Ultra/Phonic Free Conductivity Gel receive FDA 510(k) clearance?

Ultra/Phonic Free Conductivity Gel received FDA 510(k) clearance on 2018-01-09, under 510(k) number K163027.

Who is the listed applicant for Ultra/Phonic Free Conductivity 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 Ultra/Phonic Free Conductivity Gel?

The FDA product code for Ultra/Phonic Free Conductivity Gel is MUI.

Pharmaceutical Innovations, Inc.를 신청인으로 등재한 기타 기록

K163026유트라/폰릭 스캔 젤 K163024유트라/폰릭 전도성 젤 K163023기타-소닉 전달 젤

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