GF85（型号 GF85-3P，GF85-SP）
K号: K242478 · 2024-09-19
广告
器械摘要
GF85 (models GF85-3P, GF85-SP) 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 2024-09-19 under 510(k) number K242478. 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 GF85 (models GF85-3P, GF85-SP)?
GF85 (models GF85-3P, GF85-SP) is a medical device that received FDA 510(k) clearance on 2024-09-19. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K242478.
When did GF85 (models GF85-3P, GF85-SP) receive FDA 510(k) clearance?
GF85 (models GF85-3P, GF85-SP) received FDA 510(k) clearance on 2024-09-19, under 510(k) number K242478.
Who is the listed applicant for GF85 (models GF85-3P, GF85-SP)?
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 GF85 (models GF85-3P, GF85-SP)?
The FDA product code for GF85 (models GF85-3P, GF85-SP) is KPR.
相关临床试验
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。
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。
广告