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FDA 510(k)

The Luco Hybrid OSA Appliance

K-Number: K160477 · 2016-07-29

ApplicantLuco Hybrid Osa Appliance, Inc.
Decision Date2016-07-29
Product CodeOCO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: OCO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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