FDA 510(k)

BMLS16-1

K-번호: K172971 · 2018-07-08

결정일2018-07-08

제품 코드NUH

자문 위원회NE

결정Substantially Equivalent

기기 요약

BMLS16-1 is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Life Systems, Inc.. It received FDA 510(k) clearance on 2018-07-08 under 510(k) number K172971. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BMLS16-1?

BMLS16-1 is a medical device that received FDA 510(k) clearance on 2018-07-08. The listed applicant is Biomedical Life Systems, Inc.. The 510(k) number is K172971.

When did BMLS16-1 receive FDA 510(k) clearance?

BMLS16-1 received FDA 510(k) clearance on 2018-07-08, under 510(k) number K172971.

Who is the listed applicant for BMLS16-1?

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

What is the FDA product code for BMLS16-1?

The FDA product code for BMLS16-1 is NUH.

관련 기기 (코드: NUH)

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

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