FDA 510(k)

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)

Número K: K152466 · 2016-05-19

Data da decisão2016-05-19

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K152466. 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 Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)?

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Prosurg, Inc.. The 510(k) number is K152466.

When did Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) receive FDA 510(k) clearance?

Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) received FDA 510(k) clearance on 2016-05-19, under 510(k) number K152466.

Who is the listed applicant for Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)?

The FDA 510(k) record lists Prosurg, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)?

The FDA product code for Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) is EOQ.

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Outros registros que listam Prosurg, Inc. como candidato(a)

K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula K152619Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)

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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