FDA 510(k)

Ultrasonic Endo Activation Device (Model:Actor I pro)

Número K: K213947 · 2022-09-08

RequerenteChangzhou Bomedent Medical Technology Co.,Ltd

Data da decisão2022-09-08

Código do produtoELC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ultrasonic Endo Activation Device (Model:Actor I pro) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K213947. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ultrasonic Endo Activation Device (Model:Actor I pro)?

Ultrasonic Endo Activation Device (Model:Actor I pro) is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K213947.

When did Ultrasonic Endo Activation Device (Model:Actor I pro) receive FDA 510(k) clearance?

Ultrasonic Endo Activation Device (Model:Actor I pro) received FDA 510(k) clearance on 2022-09-08, under 510(k) number K213947.

Who is the listed applicant for Ultrasonic Endo Activation Device (Model:Actor I pro)?

The FDA 510(k) record lists Changzhou Bomedent Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasonic Endo Activation Device (Model:Actor I pro)?

The FDA product code for Ultrasonic Endo Activation Device (Model:Actor I pro) is ELC.

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