The Panthera Anti-Snoring X3 Device— 510(k) K171576
Substantially EquivalentPanthera Dental, Inc.
FDA 510(k) clearance K171576 for The Panthera Anti-Snoring X3 Device, Substantially Equivalent on 2018-02-22. Applicant: Panthera Dental, Inc..
Clearance details
- Applicant
- Panthera Dental, Inc.
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Quebec City, CA
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.