FDA 510(k)

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System

K-번호: K173477 · 2018-08-31

결정일2018-08-31

제품 코드ONB

자문 위원회HO

결정Substantially Equivalent

기기 요약

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K173477. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Icu Medical, Inc.. The 510(k) number is K173477.

When did ChemoCLAVE Cytotoxic Medication Preparation and Delivery System receive FDA 510(k) clearance?

ChemoCLAVE Cytotoxic Medication Preparation and Delivery System received FDA 510(k) clearance on 2018-08-31, under 510(k) number K173477.

Who is the listed applicant for ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

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

What is the FDA product code for ChemoCLAVE Cytotoxic Medication Preparation and Delivery System?

The FDA product code for ChemoCLAVE Cytotoxic Medication Preparation and Delivery System is ONB.

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