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FDA 510(k)

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

N.º K: K213972 · 2022-02-17

SolicitanteGe Healthcare Information Technologies, Inc.
Fecha de decisión2022-02-17
Código de productoDQK
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Information Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K213972. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX?

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Ge Healthcare Information Technologies, Inc.. The 510(k) number is K213972.

When did Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX receive FDA 510(k) clearance?

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX received FDA 510(k) clearance on 2022-02-17, under 510(k) number K213972.

Who is the listed applicant for Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX?

The FDA 510(k) record lists Ge Healthcare Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX?

The FDA product code for Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX is DQK.

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Dispositivos relacionados (Código: DQK)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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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.

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