FDA 510(k)

Infinity® Acute Care System (IACS) – VG8.1

N.º K: K260579 · 2026-08-20

SolicitanteDraeger Medical Systems, Inc.

Fecha de decisión2026-08-20

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Infinity® Acute Care System (IACS) – VG8.1 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 2026-08-20 under 510(k) number K260579. 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) – VG8.1?

Infinity® Acute Care System (IACS) – VG8.1 is a medical device that received FDA 510(k) clearance on 2026-08-20. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K260579.

When did Infinity® Acute Care System (IACS) – VG8.1 receive FDA 510(k) clearance?

Infinity® Acute Care System (IACS) – VG8.1 recibió la aprobación FDA 510(k) el 2026-08-20, bajo el número de 510(k) K260579.

Who is the listed applicant for Infinity® Acute Care System (IACS) – VG8.1?

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) – VG8.1?

The FDA product code for Infinity® Acute Care System (IACS) – VG8.1 is MHX.

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

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Fuente oficial

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