Medtronic Temporary External Pacemaker 53401
K号: K162054 · 2016-10-18
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器械摘要
Medtronic Temporary External Pacemaker 53401 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162054. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Medtronic Temporary External Pacemaker 53401?
Medtronic Temporary External Pacemaker 53401 is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Medtronic, Inc.. The 510(k) number is K162054.
When did Medtronic Temporary External Pacemaker 53401 receive FDA 510(k) clearance?
Medtronic Temporary External Pacemaker 53401 received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162054.
Who is the listed applicant for Medtronic Temporary External Pacemaker 53401?
The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medtronic Temporary External Pacemaker 53401?
The FDA product code for Medtronic Temporary External Pacemaker 53401 is DTE.
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列明Medtronic, Inc.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。
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相关器械（代码：DTE）
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。
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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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