FDA 510(k)

소스 프로덕션 & 장비 회사, 주식회사 모델 M14 192아이리디움 브라키터라피 소스

K-번호: K162573 · 2016-11-04

신청자Source Production and Equipment Co., Inc.

결정일2016-11-04

제품 코드KXK

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

결정대체적으로 동일

기기 요약

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is the device name listed in this FDA 510(k) record. The listed applicant is Source Production and Equipment Co., Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K162573. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Source Production and Equipment Co., Inc.. The 510(k) number is K162573.

When did Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source receive FDA 510(k) clearance?

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162573.

Who is the listed applicant for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

The FDA 510(k) record lists Source Production and Equipment Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source?

The FDA product code for Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source is KXK.

Source Production and Equipment Co., Inc.를 신청인으로 등재한 기타 기록

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