GM85
K号: K242651 · 2024-10-01
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器械摘要
GM85 is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-10-01 under 510(k) number K242651. 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 GM85?
GM85 is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K242651.
When did GM85 receive FDA 510(k) clearance?
GM85 received FDA 510(k) clearance on 2024-10-01, under 510(k) number K242651.
Who is the listed applicant for GM85?
FDA 510(k)记录将三星电子株式会社列为申请人。这本身并不足以确立该设备的制造商。
What is the FDA product code for GM85?
The FDA product code for GM85 is IZL.
列明Samsung Electronics 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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