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FDA 510(k)

Neuromonitoring Kit

K号: K161893 · 2016-10-18

申请人SI-BONE, Inc.
决定日期2016-10-18
产品代码PDQ
咨询委员会EN
决定Substantially Equivalent

器械摘要

Neuromonitoring Kit is the device name listed in this FDA 510(k) record. The listed applicant is SI-BONE, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K161893. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neuromonitoring Kit?

Neuromonitoring Kit is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is SI-BONE, Inc.. The 510(k) number is K161893.

When did Neuromonitoring Kit receive FDA 510(k) clearance?

Neuromonitoring Kit received FDA 510(k) clearance on 2016-10-18, under 510(k) number K161893.

Who is the listed applicant for Neuromonitoring Kit?

The FDA 510(k) record lists SI-BONE, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neuromonitoring Kit?

The FDA product code for Neuromonitoring Kit is PDQ.

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