FDA 510(k)

Pasteur Pipette 3mL, Pasteur Pipette 1mL

Número K: K201213 · 2020-12-16

Data da decisão2020-12-16

Código do produtoMQK

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pasteur Pipette 3mL, Pasteur Pipette 1mL is the device name listed in this FDA 510(k) record. The listed applicant is Hertart Aps. It received FDA 510(k) clearance on 2020-12-16 under 510(k) number K201213. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pasteur Pipette 3mL, Pasteur Pipette 1mL?

Pasteur Pipette 3mL, Pasteur Pipette 1mL is a medical device that received FDA 510(k) clearance on 2020-12-16. The listed applicant is Hertart Aps. The 510(k) number is K201213.

When did Pasteur Pipette 3mL, Pasteur Pipette 1mL receive FDA 510(k) clearance?

Pasteur Pipette 3mL, Pasteur Pipette 1mL received FDA 510(k) clearance on 2020-12-16, under 510(k) number K201213.

Who is the listed applicant for Pasteur Pipette 3mL, Pasteur Pipette 1mL?

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

What is the FDA product code for Pasteur Pipette 3mL, Pasteur Pipette 1mL?

The FDA product code for Pasteur Pipette 3mL, Pasteur Pipette 1mL is MQK.

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