SNORERX 9.0— 510(k) K112205

Substantially Equivalent

Consumer Health Products, Inc.

FDA 510(k) clearance K112205 for SNORERX 9.0, Substantially Equivalent on 2011-11-16. Applicant: Consumer Health Products, Inc..

Clearance details

Applicant
Consumer Health Products, Inc.
Product code
Code LRK
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Aliso Viejo, CA, US
Download summary PDFView 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.