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FDA 510(k)

SP NEWTRON CAN-A; 模块 NEWTRON CAN-A EMB; 支持 XINETIC; NWT CAN SLIM LED CORD G3 短; NWT CAN SLIM LED CORD G3 长

K号: K233922 · 2024-03-11

申请人Satelec - Acteon Group
决定日期2024-03-11
产品代码ELC
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决定实质等同

器械摘要

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG is the device name listed in this FDA 510(k) record. The listed applicant is Satelec - Acteon Group. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K233922. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG?

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Satelec - Acteon Group. The 510(k) number is K233922.

When did SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG receive FDA 510(k) clearance?

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG received FDA 510(k) clearance on 2024-03-11, under 510(k) number K233922.

Who is the listed applicant for SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG?

The FDA 510(k) record lists Satelec - Acteon Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG?

The FDA product code for SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG is ELC.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Satelec - Acteon Group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。

K172137PIEZOTOME CUBE

相关器械（代码：ELC）

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。

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX 放大镜系统（VA170LUXS10）；VARIOS 170 LUX 放大镜系统（VA170LUXS11）；VARIOS 170 放大镜系统（VA170S11）Nakanishi, Inc.K242317集成式内窥镜系统（Meet Endo-II）Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707超声波洁牙器（WD-JY-B002，WD-JY-W001，WD-JY-R003，WD-JY-G004，WD-JY-B003，WD-JY-C006，WD-JY-M0014，WD-JY-N0015，WD-JY-N0016，WD-JY-N0017，WD-JY-E007，WD-JY-F008，WD-JY-A005，WD-JY-H009，WD-JY-I0011，WD-JY-K0012，WD-JY-K0013，WD-JY-K0014，WD-JY-L0013，WD-JY-L0014，WD-JY-L0015，WD-JY-L0016，WD-JY-L0017）Shenzhen Micro Electric Intelligence Co., Ltd.

官方来源

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