FDA 510(k)

Infinity CentralStation Wide

N.º K: K240312 · 2024-08-01

SolicitanteDraeger Medical Systems, Inc.

Fecha de decisión2024-08-01

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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

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

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: MHX)

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland Oy K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.