FDA 510(k)

Single-Use Video Bronchoscopes, Digital Controller

Номер K: K213782 · 2022-07-08

Дата решения2022-07-08

Код продуктаEOQ

Консультативный комитетEN

РешениеSubstantially Equivalent

Описание устройства

Single-Use Video Bronchoscopes, Digital Controller is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Lts. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K213782. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Single-Use Video Bronchoscopes, Digital Controller?

Single-Use Video Bronchoscopes, Digital Controller is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Micro-Tech (Nanjing) Co., Lts. The 510(k) number is K213782.

When did Single-Use Video Bronchoscopes, Digital Controller receive FDA 510(k) clearance?

Single-Use Video Bronchoscopes, Digital Controller received FDA 510(k) clearance on 2022-07-08, under 510(k) number K213782.

Who is the listed applicant for Single-Use Video Bronchoscopes, Digital Controller?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Lts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Video Bronchoscopes, Digital Controller?

The FDA product code for Single-Use Video Bronchoscopes, Digital Controller is EOQ.

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: EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Официальный источник

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