BONX805
K号: K243864 · 2025-09-12
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器械摘要
BONX805 is the device name listed in this FDA 510(k) record. The listed applicant is Bontech Co., Ltd.. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K243864. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BONX805?
BONX805 is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Bontech Co., Ltd.. The 510(k) number is K243864.
When did BONX805 receive FDA 510(k) clearance?
BONX805 received FDA 510(k) clearance on 2025-09-12, under 510(k) number K243864.
Who is the listed applicant for BONX805?
The FDA 510(k) record lists Bontech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BONX805?
The FDA product code for BONX805 is IZL.
列明Bontech Co., Ltd.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。
相关器械（代码：IZL）
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。
K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058便携式DR成像系统Shantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO 移动X光系统（型号：RAYMO）DRGEM CorporationK253185Lux HD 探测器，DRX-LC 探测器，DRX-Revolution 移动X射线系统Carestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F（AirRay-mini）Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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