FDA 510(k)

Infinity Acute Care System (IACS) Monitoring System

Número K: K203088 · 2022-02-01

Data da decisão2022-02-01

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infinity Acute Care System (IACS) Monitoring System 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 2022-02-01 under 510(k) number K203088. 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 Acute Care System (IACS) Monitoring System?

Infinity Acute Care System (IACS) Monitoring System is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K203088.

When did Infinity Acute Care System (IACS) Monitoring System receive FDA 510(k) clearance?

Infinity Acute Care System (IACS) Monitoring System received FDA 510(k) clearance on 2022-02-01, under 510(k) number K203088.

Who is the listed applicant for Infinity Acute Care System (IACS) Monitoring System?

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 Acute Care System (IACS) Monitoring System?

The FDA product code for Infinity Acute Care System (IACS) Monitoring System is MHX.

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

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Fonte oficial

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