FDA 510(k)

捆绑神经分流和配件产品系列标签修改以支持 MR 条件标签

K号: K153041 · 2016-03-14

决定日期2016-03-14

产品代码JXG

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决定实质等同

器械摘要

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-03-14 under 510(k) number K153041. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is a medical device that received FDA 510(k) clearance on 2016-03-14. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K153041.

When did Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling receive FDA 510(k) clearance?

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling received FDA 510(k) clearance on 2016-03-14, under 510(k) number K153041.

Who is the listed applicant for Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling?

The FDA product code for Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is JXG.