510(k) K062943— POLYSMITH SLEEP SYSTEM, MODEL NTI5498
Substantially EquivalentNeurotronics, Inc.
Clearance details
- Applicant
- Neurotronics, Inc.
- Product code
- Code OLZ
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.