GC70
K号: K182647 · 2018-10-24
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器械摘要
GC70 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 2018-10-24 under 510(k) number K182647. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the GC70?
GC70 is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K182647.
When did GC70 receive FDA 510(k) clearance?
GC70 received FDA 510(k) clearance on 2018-10-24, under 510(k) number K182647.
Who is the listed applicant for GC70?
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 GC70?
The FDA product code for GC70 is KPR.
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：KPR）
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。
K260227EXSYS DEXi（EXSYS DEXi-S40S）；EXSYS DEXi（EXSYS DEXi-S40P）；EXSYS DEXi（EXSYS DEXi-S40T）；EXSYS DEXi（EXSYS DEXi-S50H）DRTECH CorporationK260488MULTIX Impact；MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X射线系统，DRX-Compass 移动X射线系统，Lux HD 35探测器，Lux HD 43探测器Carestream Health
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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