SmartSpectra 生命体征监测仪 1.0
K号: K254169 · 2026-06-18
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决定日期2026-06-18
产品代码QME
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]
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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
SmartSpectra Vital Signs Monitor 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Presage Security, Inc. d/b/a Presage Technologies, Inc.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K254169. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SmartSpectra Vital Signs Monitor 1.0?
SmartSpectra Vital Signs Monitor 1.0 is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Presage Security, Inc. d/b/a Presage Technologies, Inc.. The 510(k) number is K254169.
When did SmartSpectra Vital Signs Monitor 1.0 receive FDA 510(k) clearance?
SmartSpectra Vital Signs Monitor 1.0 received FDA 510(k) clearance on 2026-06-18, under 510(k) number K254169.
Who is the listed applicant for SmartSpectra Vital Signs Monitor 1.0?
The FDA 510(k) record lists Presage Security, Inc. d/b/a Presage Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartSpectra Vital Signs Monitor 1.0?
The FDA product code for SmartSpectra Vital Signs Monitor 1.0 is QME.
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。
相关器械（代码：QME）
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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