WAVESTATE NEUROMONITOR— 510(k) K092625
Substantially EquivalentWavestate, Inc.
FDA 510(k) clearance K092625 for WAVESTATE NEUROMONITOR, Substantially Equivalent on 2010-06-29. Applicant: Wavestate, Inc.. Device class: 2.
Clearance details
- Applicant
- Wavestate, Inc.
- Product code
- Code ORT
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.