Pulse Rx 2.0，Pulse Pro Rx 2.0
K号: K183328 · 2018-12-21
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决定日期2018-12-21
产品代码JOW
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
---
请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
Pulse Rx 2.0, Pulse Pro Rx 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is NormaTec Industries, LP. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K183328. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pulse Rx 2.0, Pulse Pro Rx 2.0?
Pulse Rx 2.0, Pulse Pro Rx 2.0 is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is NormaTec Industries, LP. The 510(k) number is K183328.
When did Pulse Rx 2.0, Pulse Pro Rx 2.0 receive FDA 510(k) clearance?
Pulse Rx 2.0, Pulse Pro Rx 2.0 received FDA 510(k) clearance on 2018-12-21, under 510(k) number K183328.
Who is the listed applicant for Pulse Rx 2.0, Pulse Pro Rx 2.0?
The FDA 510(k) record lists NormaTec Industries, LP as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pulse Rx 2.0, Pulse Pro Rx 2.0?
The FDA product code for Pulse Rx 2.0, Pulse Pro Rx 2.0 is JOW.
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NormaTec Industries, LP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：JOW）
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。
K261807顺序循环器（SC-4004-DL，SC-4008-DL）Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus 高级气动压缩系统Tactile MedicalK253386DVT 服装Vistar Medical Supplies Co., Ltd.K250242压缩治疗设备（LGT-2202DVT）Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.
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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