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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 the device name listed in this FDA 510(k) record. The listed applicant is Fissiontech, LLC. It received FDA 510(k) clearance on 2024-04-18 under 510(k) 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. The listed applicant is Fissiontech, LLC. The 510(k) number is K233850.

When did Difiney Anti Snoring Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Difiney Anti Snoring Device?

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

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

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

Other records listing Fissiontech, LLC 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.

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

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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