FDA 510(k)

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

Número K: K250179 · 2025-07-29

Data da decisão2025-07-29

Código do produtoMHX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-07-29 under 510(k) number K250179. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)?

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) is a medical device that received FDA 510(k) clearance on 2025-07-29. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K250179.

When did Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) receive FDA 510(k) clearance?

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) received FDA 510(k) clearance on 2025-07-29, under 510(k) number K250179.

Who is the listed applicant for Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)?

The FDA product code for Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) is MHX.

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Fonte oficial

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