FDA 510(k)

BFlex™ 2 Slim 3.8 Single-Use Bronchoscope

N.º K: K230948 · 2023-05-03

SolicitanteVerathon Medical (Canada) Ulc

Fecha de decisión2023-05-03

Código de productoEOQ

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is the device name listed in this FDA 510(k) record. The listed applicant is Verathon Medical (Canada) Ulc. It received FDA 510(k) clearance on 2023-05-03 under 510(k) number K230948. 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 BFlex™ 2 Slim 3.8 Single-Use Bronchoscope?

BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is a medical device that received FDA 510(k) clearance on 2023-05-03. The listed applicant is Verathon Medical (Canada) Ulc. The 510(k) number is K230948.

When did BFlex™ 2 Slim 3.8 Single-Use Bronchoscope receive FDA 510(k) clearance?

BFlex™ 2 Slim 3.8 Single-Use Bronchoscope received FDA 510(k) clearance on 2023-05-03, under 510(k) number K230948.

Who is the listed applicant for BFlex™ 2 Slim 3.8 Single-Use Bronchoscope?

The FDA 510(k) record lists Verathon Medical (Canada) Ulc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BFlex™ 2 Slim 3.8 Single-Use Bronchoscope?

The FDA product code for BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is EOQ.

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Otros registros que enlistan a Verathon Medical (Canada) Ulc como solicitante

K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)K211947GlideScope BFlex 2.8 Single-Use Bronchoscope K193488GlideScope BFlex 3.8 Single-Use Bronchoscope K191948GlideScope BFlex 5.8 Single-Use Bronchoscope K183256GlideScope BFlex Single-Use Bronchoscope System

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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