LUNA— 510(k) K982351
Substantially EquivalentStellate Systems
FDA 510(k) clearance K982351 for LUNA, Substantially Equivalent on 1998-07-29. Applicant: Stellate Systems.
Clearance details
- Applicant
- Stellate Systems
- Product code
- Code OLT
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Canada, H32 2n2, CA
Adverse events under product code OLT
product code OLT- Other
- 1
- Total
- 1
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.