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FDA 510(k)

Fuselier Intraoral Nighttime Device (FIND)

K-Number: K161980 · 2017-02-07

ApplicantFuselier Enterprises, LLC
Decision Date2017-02-07
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Fuselier Intraoral Nighttime Device (FIND) is the device name listed in this FDA 510(k) record. The listed applicant is Fuselier Enterprises, LLC. It received FDA 510(k) clearance on 2017-02-07 under 510(k) number K161980. 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 Fuselier Intraoral Nighttime Device (FIND)?

Fuselier Intraoral Nighttime Device (FIND) is a medical device that received FDA 510(k) clearance on 2017-02-07. The listed applicant is Fuselier Enterprises, LLC. The 510(k) number is K161980.

When did Fuselier Intraoral Nighttime Device (FIND) receive FDA 510(k) clearance?

Fuselier Intraoral Nighttime Device (FIND) received FDA 510(k) clearance on 2017-02-07, under 510(k) number K161980.

Who is the listed applicant for Fuselier Intraoral Nighttime Device (FIND)?

The FDA 510(k) record lists Fuselier Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fuselier Intraoral Nighttime Device (FIND)?

The FDA product code for Fuselier Intraoral Nighttime Device (FIND) is LRK.

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

Official Source

View on FDA Database →

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

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