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FDA 510(k)

The Luco Hybrid OSA Appliance

K号: K160477 · 2016-07-29

决定日期2016-07-29
产品代码OCO
决定实质等同

器械摘要

The Luco Hybrid OSA Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Luco Hybrid Osa Appliance, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K160477. The device is classified under product code OCO. FDA Decision: Substantially Equivalent.

常见问题

What is the The Luco Hybrid OSA Appliance?

The Luco Hybrid OSA Appliance is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Luco Hybrid Osa Appliance, Inc.. The 510(k) number is K160477.

When did The Luco Hybrid OSA Appliance receive FDA 510(k) clearance?

The Luco Hybrid OSA Appliance received FDA 510(k) clearance on 2016-07-29, under 510(k) number K160477.

Who is the listed applicant for The Luco Hybrid OSA Appliance?

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

What is the FDA product code for The Luco Hybrid OSA Appliance?

The FDA product code for The Luco Hybrid OSA Appliance is OCO.

相关临床试验

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相关器械(代码:OCO)

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