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FDA 510(k)

OrthoScan TAU Mini C-Arm

K号: K183220 · 2019-06-21

决定日期2019-06-21
产品代码OXO
咨询委员会RA
决定实质等同

器械摘要

OrthoScan TAU Mini C-Arm is the device name listed in this FDA 510(k) record. The listed applicant is Orthoscan, Inc.. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K183220. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OrthoScan TAU Mini C-Arm?

OrthoScan TAU Mini C-Arm is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Orthoscan, Inc.. The 510(k) number is K183220.

When did OrthoScan TAU Mini C-Arm receive FDA 510(k) clearance?

OrthoScan TAU Mini C-Arm received FDA 510(k) clearance on 2019-06-21, under 510(k) number K183220.

Who is the listed applicant for OrthoScan TAU Mini C-Arm?

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

What is the FDA product code for OrthoScan TAU Mini C-Arm?

The FDA product code for OrthoScan TAU Mini C-Arm is OXO.

相关临床试验

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列明Orthoscan, Inc.为申报人的其他记录

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相关器械(代码:OXO)

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官方来源

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