FDA 510(k)

GlideScope BFlex 5.8 单次使用支气管镜

K号: K191948 · 2019-08-21

决定日期2019-08-21

产品代码EOQ

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决定实质等同

器械摘要

GlideScope BFlex 5.8 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 2019-08-21 under 510(k) number K191948. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GlideScope BFlex 5.8 Single-Use Bronchoscope?

GlideScope BFlex 5.8 Single-Use Bronchoscope is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Verathon Medical (Canada) Ulc. The 510(k) number is K191948.

When did GlideScope BFlex 5.8 Single-Use Bronchoscope receive FDA 510(k) clearance?

GlideScope BFlex 5.8 Single-Use Bronchoscope received FDA 510(k) clearance on 2019-08-21, under 510(k) number K191948.

Who is the listed applicant for GlideScope BFlex 5.8 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 GlideScope BFlex 5.8 Single-Use Bronchoscope?

The FDA product code for GlideScope BFlex 5.8 Single-Use Bronchoscope is EOQ.

列明Verathon Medical (Canada) Ulc为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253696CFlex膀胱镜 - 标准偏转（0570-0455）；CFlex膀胱镜 - 反向偏转（0570-0456）；CystoView监视器（0570-0465）K230948BFlex™ 2 Slim 3.8 Single-Use Bronchoscope K211947GlideScope BFlex 2.8 单次使用支气管镜 K193488GlideScope BFlex 3.8 单次使用支气管镜 K183256GlideScope BFlex 单次使用支气管镜系统

相关器械（代码：EOQ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261637一次性使用柔性支气管镜Hunan 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 样本套装Ambu A/S K2540263.8mm 精薄型 ProVu 视频支气管镜（090-02-0038U）；5.0mm 标准型 ProVu 视频支气管镜（090-02-0050U）；6.0mm 大型 ProVu 视频支气管镜（090-02-0060U）；ProVu 视频支气管镜 8 显示器（040-07-0082U）Flexicare Medical Limited.K260382MONARCH™ 平台（MON-000008）Auris Health, Inc.K254037LungFlow气道导管Free Flow Medical, Inc.K253137富士胶片内窥镜型号EB-840S; 富士胶片内窥镜型号EB-840TFujifilm Corporation

官方来源

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