FDA 510(k)

통합된 캡추 프리덤 주사기 주입 시스템

K-번호: K162613 · 2017-08-31

신청자Repro-Med Systems, Inc. Dba Rms Medical Products

결정일2017-08-31

제품 코드FRN

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

결정대체적으로 동일

기기 요약

Integrated Catch-up Freedom Syringe Driver Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc. Dba Rms Medical Products. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K162613. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Integrated Catch-up Freedom Syringe Driver Infusion System?

Integrated Catch-up Freedom Syringe Driver Infusion System is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Repro-Med Systems, Inc. Dba Rms Medical Products. The 510(k) number is K162613.

When did Integrated Catch-up Freedom Syringe Driver Infusion System receive FDA 510(k) clearance?

Integrated Catch-up Freedom Syringe Driver Infusion System received FDA 510(k) clearance on 2017-08-31, under 510(k) number K162613.

Who is the listed applicant for Integrated Catch-up Freedom Syringe Driver Infusion System?

The FDA 510(k) record lists Repro-Med Systems, Inc. Dba Rms Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Integrated Catch-up Freedom Syringe Driver Infusion System?

The FDA product code for Integrated Catch-up Freedom Syringe Driver Infusion System is FRN.

Repro-Med Systems, Inc. Dba Rms Medical Products를 신청인으로 등재한 기타 기록

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