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FDA 510(k)

Difiney Anti Snoring Device

K-Number: K233850 · 2024-04-18

ApplicantFissiontech, LLC
Decision Date2024-04-18
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Difiney Anti Snoring Device is a medical device manufactured by Fissiontech, LLC. It received FDA 510(k) clearance on 2024-04-18 under approval number K233850. 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 Difiney Anti Snoring Device?

Difiney Anti Snoring Device is a medical device that received FDA 510(k) clearance on 2024-04-18. It is manufactured by Fissiontech, LLC. The 510(k) number is K233850.

When was Difiney Anti Snoring Device approved by the FDA?

Difiney Anti Snoring Device received FDA 510(k) clearance on 2024-04-18, under approval number K233850.

What company makes Difiney Anti Snoring Device?

Difiney Anti Snoring Device is manufactured by Fissiontech, LLC.

What is the FDA product code for Difiney Anti Snoring Device?

The FDA product code for Difiney Anti Snoring Device is LRK.

Related Clinical Trials

NCT04092660 Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea. RECRUITING

Other Devices by Fissiontech, LLC

K253355Difiney Advanced Anti Snoring Device 4.0 K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue

Related Devices (Code: LRK)

K162192BlueProBluesom K152660HYPNOSPADSomnics, Inc. K161832O2VENT TOventus Manufacturing Pty, Ltd. K162306SomnoDent ALPHASomnomed, Inc. K160531NoiselezzFirma Ingemarsson K153200SnoreRxApnea Sciences Corporation

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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