FDA 510(k)

The Luco Hybrid OSA Appliance

K-번호: K160477 · 2016-07-29

결정일2016-07-29

제품 코드OCO

결정Substantially Equivalent

기기 요약

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.

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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.

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The Luco Hybrid OSA Appliance

기기 요약

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관련 임상시험

관련 기기 (코드: OCO)

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