VPAP Adapt SV，VPAP Tx，S9 VPAP Tx
K号: K161487 · 2016-09-09
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申请人Resmed, Ltd.
决定日期2016-09-09
产品代码MNS
咨询委员会AN
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器械摘要
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K161487. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Resmed, Ltd.. The 510(k) number is K161487.
When did VPAP Adapt SV, VPAP Tx, S9 VPAP Tx receive FDA 510(k) clearance?
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161487.
Who is the listed applicant for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?
The FDA 510(k) record lists Resmed, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx?
The FDA product code for VPAP Adapt SV, VPAP Tx, S9 VPAP Tx is MNS. This falls under the Neurology category.
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Resmed, Ltd.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：MNS）
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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