SureTouch 移动压力映射系统
K号: K181672 · 2019-06-28
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申请人Sure, Inc.
决定日期2019-06-28
产品代码NKA
咨询委员会OB
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决定实质等同
器械摘要
SureTouch Mobile Pressure Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Sure, Inc.. It received FDA 510(k) clearance on 2019-06-28 under 510(k) number K181672. The device is classified under product code NKA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SureTouch Mobile Pressure Mapping System?
SureTouch Mobile Pressure Mapping System is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Sure, Inc.. The 510(k) number is K181672.
When did SureTouch Mobile Pressure Mapping System receive FDA 510(k) clearance?
SureTouch Mobile Pressure Mapping System received FDA 510(k) clearance on 2019-06-28, under 510(k) number K181672.
Who is the listed applicant for SureTouch Mobile Pressure Mapping System?
The FDA 510(k) record lists Sure, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SureTouch Mobile Pressure Mapping System?
The FDA product code for SureTouch Mobile Pressure Mapping System is NKA.
相关临床试验
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相关器械（代码：NKA）
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。
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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