FDA 510(k)

Infinity CentralStation Wide

Número K: K240312 · 2024-08-01

Data da decisão2024-08-01

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infinity CentralStation Wide 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 2024-08-01 under 510(k) number K240312. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Infinity CentralStation Wide?

Infinity CentralStation Wide is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K240312.

When did Infinity CentralStation Wide receive FDA 510(k) clearance?

Infinity CentralStation Wide received FDA 510(k) clearance on 2024-08-01, under 510(k) number K240312.

Who is the listed applicant for Infinity CentralStation Wide?

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 Infinity CentralStation Wide?

The FDA product code for Infinity CentralStation Wide is MHX.

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Outros registros que listam Draeger Medical Systems, Inc. como candidato(a)

K260579Infinity® Acute Care System (IACS) – VG8.1 K243606Babyroo TN300 K233834Infinity Gateway Suite K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+K230278Babyroo TN300 K203579Infinity Gateway Suite

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Fonte oficial

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