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FDA 510(k)

nView系统1

K号: K190064 · 2019-07-08

决定日期2019-07-08
产品代码OWB
咨询委员会RA
决定实质等同

器械摘要

nView system 1 is the device name listed in this FDA 510(k) record. The listed applicant is Nview Medical, Inc.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K190064. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the nView system 1?

nView system 1 is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is Nview Medical, Inc.. The 510(k) number is K190064.

When did nView system 1 receive FDA 510(k) clearance?

nView system 1 received FDA 510(k) clearance on 2019-07-08, under 510(k) number K190064.

Who is the listed applicant for nView system 1?

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

What is the FDA product code for nView system 1?

The FDA product code for nView system 1 is OWB.

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相关器械(代码:OWB)

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官方来源

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