FDA 510(k)

Fiber Optic Brushless Electronic Micromotor, model: iM100

Номер K: K231864 · 2024-03-11

ЗаявительCodent Technical Industry Co., Ltd.

Дата решения2024-03-11

Код продуктаEBW

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Fiber Optic Brushless Electronic Micromotor, model: iM100 is the device name listed in this FDA 510(k) record. The listed applicant is Codent Technical Industry Co., Ltd.. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K231864. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Fiber Optic Brushless Electronic Micromotor, model: iM100?

Fiber Optic Brushless Electronic Micromotor, model: iM100 is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Codent Technical Industry Co., Ltd.. The 510(k) number is K231864.

When did Fiber Optic Brushless Electronic Micromotor, model: iM100 receive FDA 510(k) clearance?

Fiber Optic Brushless Electronic Micromotor, model: iM100 received FDA 510(k) clearance on 2024-03-11, under 510(k) number K231864.

Who is the listed applicant for Fiber Optic Brushless Electronic Micromotor, model: iM100?

The FDA 510(k) record lists Codent Technical Industry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fiber Optic Brushless Electronic Micromotor, model: iM100?

The FDA product code for Fiber Optic Brushless Electronic Micromotor, model: iM100 is EBW.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: EBW)

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental Division K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

Официальный источник

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