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FDA 510(k)

BMLS16-1

Número K: K172971 · 2018-07-08

RequerenteBiomedical Life Systems, Inc.
Data da decisão2018-07-08
Código do produtoNUH
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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