FDA 510(k)

WHOOP ECG (electrocardiogram) Feature (1.0)

Número K: K243236 · 2025-04-04

Data da decisão2025-04-04

Código do produtoQDA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

WHOOP ECG (electrocardiogram) Feature (1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Whoop., Inc.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K243236. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WHOOP ECG (electrocardiogram) Feature (1.0)?

WHOOP ECG (electrocardiogram) Feature (1.0) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Whoop., Inc.. The 510(k) number is K243236.

When did WHOOP ECG (electrocardiogram) Feature (1.0) receive FDA 510(k) clearance?

WHOOP ECG (electrocardiogram) Feature (1.0) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K243236.

Who is the listed applicant for WHOOP ECG (electrocardiogram) Feature (1.0)?

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

What is the FDA product code for WHOOP ECG (electrocardiogram) Feature (1.0)?

The FDA product code for WHOOP ECG (electrocardiogram) Feature (1.0) is QDA.

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