FDA 510(k)

GALILEO 脊柱对齐监测系统

K号: K182524 · 2019-06-17

决定日期2019-06-17

产品代码OLO

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决定实质等同

器械摘要

GALILEO Spine Alignment Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2019-06-17 under 510(k) number K182524. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GALILEO Spine Alignment Monitoring System?

GALILEO Spine Alignment Monitoring System is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is MiRus, LLC. The 510(k) number is K182524.

When did GALILEO Spine Alignment Monitoring System receive FDA 510(k) clearance?

GALILEO Spine Alignment Monitoring System received FDA 510(k) clearance on 2019-06-17, under 510(k) number K182524.

Who is the listed applicant for GALILEO Spine Alignment Monitoring System?

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

What is the FDA product code for GALILEO Spine Alignment Monitoring System?

The FDA product code for GALILEO Spine Alignment Monitoring System is OLO.

列明MiRus, LLC为申报人的其他记录

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