FDA 510(k)

NAR 쇼츠 셔틀; NAR 쇼츠 셔틀 6개 팩

K-번호: K152340 · 2016-05-31

결정일2016-05-31

제품 코드MMK

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six is the device name listed in this FDA 510(k) record. The listed applicant is North American Rescue, LLC. It received FDA 510(k) clearance on 2016-05-31 under 510(k) number K152340. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six?

NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six is a medical device that received FDA 510(k) clearance on 2016-05-31. The listed applicant is North American Rescue, LLC. The 510(k) number is K152340.

When did NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six receive FDA 510(k) clearance?

NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six received FDA 510(k) clearance on 2016-05-31, under 510(k) number K152340.

Who is the listed applicant for NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six?

The FDA 510(k) record lists North American Rescue, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six?

The FDA product code for NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six is MMK.

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NAR 쇼츠 셔틀; NAR 쇼츠 셔틀 6개 팩

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: MMK)

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