DeviceClearance

Difiney Anti Snoring Device— 510(k) K233850

Substantially Equivalent

Fissiontech, LLC

FDA 510(k) clearance K233850 for Difiney Anti Snoring Device, Substantially Equivalent on 2024-04-18. Applicant: Fissiontech, LLC. Device class: 2.

Clearance details

Applicant
Fissiontech, LLC
Product code
Code LRK
Device class
Class 2
Regulation
21 CFR 872.5570
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LRK

product code LRK
Injury
246
Malfunction
1,044
Total
1,290

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.