FDA 510(k)

MicroPlex Coil System (MCS) - HyperSoft 3D

K 號：K161452 · 2016-08-31

決定日期2016-08-31

產品代碼HCG

諮詢委員會NE

決定Substantially Equivalent

器材摘要

MicroPlex Coil System (MCS) - HyperSoft 3D is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K161452. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MicroPlex Coil System (MCS) - HyperSoft 3D?

MicroPlex Coil System (MCS) - HyperSoft 3D is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is MicroVention, Inc.. The 510(k) number is K161452.

When did MicroPlex Coil System (MCS) - HyperSoft 3D receive FDA 510(k) clearance?

MicroPlex Coil System (MCS) - HyperSoft 3D received FDA 510(k) clearance on 2016-08-31, under 510(k) number K161452.

Who is the listed applicant for MicroPlex Coil System (MCS) - HyperSoft 3D?

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

What is the FDA product code for MicroPlex Coil System (MCS) - HyperSoft 3D?

The FDA product code for MicroPlex Coil System (MCS) - HyperSoft 3D is HCG.

其他以 MicroVention, Inc. 為申請人之記錄

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相關器械（代碼：HCG）

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