FDA 510(k)

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

K-번호: K163283 · 2017-09-20

결정일2017-09-20

제품 코드BTT

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

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기기 요약

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical AG. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K163283. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Hamilton Medical AG. The 510(k) number is K163283.

When did HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 receive FDA 510(k) clearance?

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 received FDA 510(k) clearance on 2017-09-20, under 510(k) number K163283.

Who is the listed applicant for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

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

What is the FDA product code for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

The FDA product code for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is BTT.

Hamilton Medical AG를 신청인으로 등재한 기타 기록

K201306햄릭슨-C3 K201658�해밀턴-C6 K193228�해밀턴-G5 K181216HAMILTON-T1, HAMILTON-C1 K161450햄릭슨-C3 K153046햄릴턴-MR1

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