FDA 510(k)

Infinity Acute Care System (IACS) Monitoring Solution

N.º K: K201764 · 2021-12-09

SolicitanteDraeger Medical Systems, Inc.

Fecha de decisión2021-12-09

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Infinity Acute Care System (IACS) Monitoring Solution 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 2021-12-09 under 510(k) number K201764. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Infinity Acute Care System (IACS) Monitoring Solution?

Infinity Acute Care System (IACS) Monitoring Solution is a medical device that received FDA 510(k) clearance on 2021-12-09. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K201764.

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

Infinity Acute Care System (IACS) Monitoring Solution received FDA 510(k) clearance on 2021-12-09, under 510(k) number K201764.

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

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 Solution?

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

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Otros registros que enlistan a Draeger Medical Systems, Inc. como solicitante

K260579Infinity® Acute Care System (IACS) – VG8.1 K243606Babyroo TN300 K240312Infinity CentralStation Wide K233834Infinity Gateway Suite K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+K230278Babyroo TN300

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Dispositivos relacionados (Código: MHX)

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Fuente oficial

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