FDA 510(k)

FUJIFILM 内窥镜型号 EB-710P

K号: K220957 · 2022-11-10

决定日期2022-11-10

产品代码EOQ

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决定实质等同

器械摘要

FUJIFILM Endoscope Model EB-710P is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporaton. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K220957. 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 FUJIFILM Endoscope Model EB-710P?

FUJIFILM Endoscope Model EB-710P is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Fujifilm Corporaton. The 510(k) number is K220957.

When did FUJIFILM Endoscope Model EB-710P receive FDA 510(k) clearance?

FUJIFILM Endoscope Model EB-710P received FDA 510(k) clearance on 2022-11-10, under 510(k) number K220957.

Who is the listed applicant for FUJIFILM Endoscope Model EB-710P?

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

What is the FDA product code for FUJIFILM Endoscope Model EB-710P?

The FDA product code for FUJIFILM Endoscope Model EB-710P is EOQ.

列明Fujifilm Corporaton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。

K221551富士胶片内窥镜型号EI-740D/S K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D K212950富士胶片视频腹腔镜 EL-R740M30 K203717Processor VP-7000，光源 BL-7000X，图像处理单元 EX-0 K200973Synapse 3D 心脏工具

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

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