TE ME NA POLYSTIM NERVE STIMILATOR— 510(k) K990323
Substantially EquivalentTe ME NA S.A.R.L.
FDA 510(k) clearance K990323 for TE ME NA POLYSTIM NERVE STIMILATOR, Substantially Equivalent on 2001-09-28. Applicant: Te ME NA S.A.R.L..
Clearance details
- Applicant
- Te ME NA S.A.R.L.
- Product code
- Code BXN
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oldsmar, FL, US
Adverse events under product code BXN
product code BXN- 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.