FDA 510(k)

홈체이스 클라리아 APD 시스템, 홈체이스 클라리아 APD 시스템과 사용할 수 있는 셰어스오스 커넥티비티 플랫폼

K-번호: K201867 · 2020-11-19

결정일2020-11-19

제품 코드FKX

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2020-11-19 under 510(k) number K201867. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is a medical device that received FDA 510(k) clearance on 2020-11-19. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K201867.

When did Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System receive FDA 510(k) clearance?

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System received FDA 510(k) clearance on 2020-11-19, under 510(k) number K201867.

Who is the listed applicant for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System?

The FDA product code for Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System is FKX.

Baxter Healthcare Corporation를 신청인으로 등재한 기타 기록

K251745웨尔斯알리언 플렉시포트 혈압링(플렉시포트 혈압링)K251640SIGMA 스펙트럼 주사泵 및 마스터 약물 라이브러리 K251636스펙트럼 IQ 주사 시스템 및 Dose IQ 안전 소프트웨어 (3570009)K243529솔루션 관리 세트 K242339내피관 확장 세트 및 액세서리 K242390노베움 IQ 주사기 펌프 (40800BAXUS)

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