A8, A9 麻醉系统
K号: K201957 · 2021-03-26
广告
决定日期2021-03-26
产品代码BSZ
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
A8, A9 Anesthesia System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K201957. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the A8, A9 Anesthesia System?
A8, A9 Anesthesia System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K201957.
When did A8, A9 Anesthesia System receive FDA 510(k) clearance?
A8, A9 Anesthesia System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K201957.
Who is the listed applicant for A8, A9 Anesthesia System?
The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for A8, A9 Anesthesia System?
The FDA product code for A8, A9 Anesthesia System is BSZ.
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Shenzhen Mindray Bio-Medical 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。
K253330A5 麻醉系统（A5）；A7 麻醉系统（A7）K260098ePM系列患者监护仪（ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC）K260846诊断超声系统 (MU9)；诊断超声系统 (MU9S)；诊断超声系统 (MU9T)；诊断超声系统 (MU9 Exp)；诊断超声系统 (MU9 Pro)；诊断超声系统 (MU9 Super)；诊断超声系统 (MU9P)；诊断超声系统 (MU9A)；诊断超声系统 (MU7)；诊断超声系统 (MU7S)；诊断超声系统 (MU7T)；诊断超声系统 (MU7 Exp)；诊断超声系统 (MU7 Pro)；诊断超声系统K253170uMEC 60/ uMEC 70/ uMEC 80/ uMEC 100/ uMEC 120/ uMEC 150 患者监护仪K252182SV70 Ventilator (SV70)K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 诊断超声系统
相关器械（代码：BSZ）
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。
K253330A5 麻醉系统（A5）；A7 麻醉系统（A7）Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)Drägerwerk AG Co. KgaaK251352Codonics安全标签系统-护理点工作站（PCS）（SLS-700i和相关610i、620i、630i系列启用RFID功能）；Codonics安全标签系统-护理点工作站（PCS）（SLS-1，SLS XXX，多个型号待配置）Codonics.IncorporatedK230931AtlanDrägerwerk AG Co. KgaaK213867Carestation 750/750cDatex-Ohmeda, Inc.K191027Flow-i 麻醉系统，Flow-c 麻醉系统，Flow-e 麻醉系统Maquet Critical Care AB
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