FDA 510(k)

Bronchoscope System

Número K: K231107 · 2024-02-15

RequerenteHunan Endoso Life Technology Co., Ltd.

Data da decisão2024-02-15

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bronchoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Endoso Life Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K231107. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bronchoscope System?

Bronchoscope System is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Hunan Endoso Life Technology Co., Ltd.. The 510(k) number is K231107.

When did Bronchoscope System receive FDA 510(k) clearance?

Bronchoscope System received FDA 510(k) clearance on 2024-02-15, under 510(k) number K231107.

Who is the listed applicant for Bronchoscope System?

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

What is the FDA product code for Bronchoscope System?

The FDA product code for Bronchoscope System is EOQ.

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Outros registros que listam Hunan Endoso Life Technology Co., Ltd. como candidato(a)

K241956Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)K231725Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

Dispositivos Relacionados (Código: 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

Fonte oficial

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