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FDA 510(k)

LUCO HYBRID OSA APPLIANCE

K-Number: K130797 · 2013-12-18

ApplicantLuco Hybrid Osa Appliance, Inc.
Decision Date2013-12-18
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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 2013-12-18 under 510(k) number K130797. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUCO HYBRID OSA APPLIANCE?

LUCO HYBRID OSA APPLIANCE is a medical device that received FDA 510(k) clearance on 2013-12-18. The listed applicant is Luco Hybrid Osa Appliance, Inc.. The 510(k) number is K130797.

When did LUCO HYBRID OSA APPLIANCE receive FDA 510(k) clearance?

LUCO HYBRID OSA APPLIANCE received FDA 510(k) clearance on 2013-12-18, under 510(k) number K130797.

Who is the listed applicant for 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 LUCO HYBRID OSA APPLIANCE?

The FDA product code for LUCO HYBRID OSA APPLIANCE is LRK.

Related Clinical Trials

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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Other records listing Luco Hybrid Osa Appliance, Inc. as applicant

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.

K160477The Luco Hybrid OSA Appliance

Related Devices (Code: LRK)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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