FDA 510(k)

富士胶片内窥镜型号EB-710XT

K号: K240075 · 2024-02-07

申请人FUJIFILM Healthcare Americas Corporation

决定日期2024-02-07

产品代码EOQ

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决定实质等同

器械摘要

FUJIFILM Endoscope Model EB-710XT is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-02-07 under 510(k) number K240075. 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-710XT?

FUJIFILM Endoscope Model EB-710XT is a medical device that received FDA 510(k) clearance on 2024-02-07. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K240075.

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

FUJIFILM Endoscope Model EB-710XT received FDA 510(k) clearance on 2024-02-07, under 510(k) number K240075.

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

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

列明FUJIFILM Healthcare Americas Corporation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。

K261713Synapse PACS (7.6.0)K251204富士胶片加固钢丝装置（SW-2000）K243647Synapse PACS (7.5)K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214C K233629APERTO 明亮 MRI 系统 K233687ECHELON 协同 V10.0

查看所有 13 个设备 →

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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