FDA 510(k)

Keikku Electronic stethoscope

Número K: K233313 · 2024-04-10

Data da decisão2024-04-10

Código do produtoDQD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Keikku Electronic stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Lapsi Health Holding B.V.. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K233313. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Keikku Electronic stethoscope?

Keikku Electronic stethoscope is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Lapsi Health Holding B.V.. The 510(k) number is K233313.

When did Keikku Electronic stethoscope receive FDA 510(k) clearance?

Keikku Electronic stethoscope received FDA 510(k) clearance on 2024-04-10, under 510(k) number K233313.

Who is the listed applicant for Keikku Electronic stethoscope?

The FDA 510(k) record lists Lapsi Health Holding B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Keikku Electronic stethoscope?

The FDA product code for Keikku Electronic stethoscope is DQD.

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