FDA 510(k)

Vathin Video Bronchoscope System

N.º K: K213635 · 2022-02-28

SolicitanteHunan Vathin Medical Instrument Co., Ltd.

Fecha de decisión2022-02-28

Código de productoEOQ

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Vathin Video Bronchoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-02-28 under 510(k) number K213635. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vathin Video Bronchoscope System?

Vathin Video Bronchoscope System is a medical device that received FDA 510(k) clearance on 2022-02-28. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K213635.

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

Vathin Video Bronchoscope System received FDA 510(k) clearance on 2022-02-28, under 510(k) number K213635.

Who is the listed applicant for Vathin Video Bronchoscope System?

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

What is the FDA product code for Vathin Video Bronchoscope System?

The FDA product code for Vathin Video Bronchoscope System is EOQ.

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Otros registros que enlistan a Hunan Vathin Medical Instrument Co., Ltd. como solicitante

K261637Single-use Flexible Bronchoscope K250232Vathin® Video Bronchoscope System K251599Single-use Ureteral Access Sheath K250785Single-use Flexible Ureteroscope K243117Digital Video Processor K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

Ver todos los 18 dispositivos →

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

Fuente oficial

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