Diamond Digital Sleep Orthotic (DDSO)— 510(k) K202499
Substantially EquivalentDiamond Orthotic Laboratory
FDA 510(k) clearance K202499 for Diamond Digital Sleep Orthotic (DDSO), Substantially Equivalent on 2020-09-03. Applicant: Diamond Orthotic Laboratory.
Clearance details
- Applicant
- Diamond Orthotic Laboratory
- Product code
- Code LRK
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Mesa, CA, US
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.