FDA 510(k)

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

N.º K: K243216 · 2024-12-10

Fecha de decisión2024-12-10

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is the device name listed in this FDA 510(k) record. The listed applicant is Analog Devices. It received FDA 510(k) clearance on 2024-12-10 under 510(k) number K243216. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is a medical device that received FDA 510(k) clearance on 2024-12-10. The listed applicant is Analog Devices. The 510(k) number is K243216.

When did Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) receive FDA 510(k) clearance?

Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) received FDA 510(k) clearance on 2024-12-10, under 510(k) number K243216.

Who is the listed applicant for Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

The FDA 510(k) record lists Analog Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)?

The FDA product code for Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) is MWI.

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