FDA 510(k)

Isolette 8000 Plus

Número K: K182977 · 2018-11-21

Data da decisão2018-11-21

Código do produtoFMZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Isolette 8000 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-11-21 under 510(k) number K182977. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Isolette 8000 Plus?

Isolette 8000 Plus is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K182977.

When did Isolette 8000 Plus receive FDA 510(k) clearance?

Isolette 8000 Plus received FDA 510(k) clearance on 2018-11-21, under 510(k) number K182977.

Who is the listed applicant for Isolette 8000 Plus?

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

What is the FDA product code for Isolette 8000 Plus?

The FDA product code for Isolette 8000 Plus is FMZ.

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Fonte oficial

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