AViTA 臂式血压计袖带
K号: K250765 · 2025-09-03
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决定日期2025-09-03
产品代码DXQ
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
AViTA Arm Type Blood Pressure Monitor Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K250765. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AViTA Arm Type Blood Pressure Monitor Cuff?
AViTA Arm Type Blood Pressure Monitor Cuff is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Avita Corporation. The 510(k) number is K250765.
When did AViTA Arm Type Blood Pressure Monitor Cuff receive FDA 510(k) clearance?
AViTA Arm Type Blood Pressure Monitor Cuff received FDA 510(k) clearance on 2025-09-03, under 510(k) number K250765.
Who is the listed applicant for AViTA Arm Type Blood Pressure Monitor Cuff?
The FDA 510(k) record lists Avita Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AViTA Arm Type Blood Pressure Monitor Cuff?
The FDA product code for AViTA Arm Type Blood Pressure Monitor Cuff is DXQ.
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Avita Corporation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：DXQ）
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。
K254287Medline 可重复使用血压袖带Medline Industries, LPK260747YP-710T系列血压计袖带；YP-840T系列一次性袖带Nihon Kohden CorporationK253089NIBP袖带（BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722）Shenzhen Best Electronics Co., Ltd.K253964一次性新生儿NIBP袖带（U1681S-C51N）Unimed Medical Supplies, Inc.K251745韦尔奇·艾略恩FlexiPort血压袖带（FlexiPort血压袖带）Baxter Healthcare CorporationK251045一次性新生儿NIBP袖带（U1682S-C51N）；一次性新生儿NIBP袖带（U1683S-C51N）；一次性新生儿NIBP袖带（U1684S-C51N）；一次性新生儿NIBP袖带（U1685S-C51N）Unimed Medical Supplies, Inc.
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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