DeviceClearance

K180124

Substantially Equivalent

ZQuiet

Applicant
Sleeping Well, LLC
Product code
LRK
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Shelburne, VT, US
Download summary PDF View on FDA.gov ↗

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.