Definium Pace Select
K号: K231892 · 2023-09-12
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器械摘要
Definium Pace Select is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K231892. 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 Definium Pace Select?
Definium Pace Select is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K231892.
When did Definium Pace Select receive FDA 510(k) clearance?
Definium Pace Select received FDA 510(k) clearance on 2023-09-12, under 510(k) number K231892.
Who is the listed applicant for Definium Pace Select?
The FDA 510(k) record lists Ge Hualun Medical Systems Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Definium Pace Select?
The FDA product code for Definium Pace Select is KPR.
相关临床试验
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列明Ge Hualun Medical Systems 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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