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FDA 510(k)

NeedleSmart Professional (NS Pro)

Número K: K202073 · 2021-03-25

RequerenteNeedlesmart Limited
Data da decisão2021-03-25
Código do produtoMTV
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

NeedleSmart Professional (NS Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Needlesmart Limited. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K202073. The device is classified under product code MTV. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NeedleSmart Professional (NS Pro)?

NeedleSmart Professional (NS Pro) is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Needlesmart Limited. The 510(k) number is K202073.

When did NeedleSmart Professional (NS Pro) receive FDA 510(k) clearance?

NeedleSmart Professional (NS Pro) received FDA 510(k) clearance on 2021-03-25, under 510(k) number K202073.

Who is the listed applicant for NeedleSmart Professional (NS Pro)?

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

What is the FDA product code for NeedleSmart Professional (NS Pro)?

The FDA product code for NeedleSmart Professional (NS Pro) is MTV.

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