FDA 510(k)

Holter ECG and ABP system (HolterABP)

Número K: K251591 · 2026-02-09

Data da decisão2026-02-09

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Holter ECG and ABP system (HolterABP) 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 2026-02-09 under 510(k) number K251591. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Holter ECG and ABP system (HolterABP)?

Holter ECG and ABP system (HolterABP) is a medical device that received FDA 510(k) clearance on 2026-02-09. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251591.

When did Holter ECG and ABP system (HolterABP) receive FDA 510(k) clearance?

Holter ECG and ABP system (HolterABP) received FDA 510(k) clearance on 2026-02-09, under 510(k) number K251591.

Who is the listed applicant for Holter ECG and ABP system (HolterABP)?

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 Holter ECG and ABP system (HolterABP)?

The FDA product code for Holter ECG and ABP system (HolterABP) is DQK.

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Fonte oficial

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