WAVESTATE NEUROMONITOR
FDA 510(k) clearance K092625 · decided 2010-06-29
Clearance details
- K-number
- K092625
- Device name
- WAVESTATE NEUROMONITOR
- Applicant
- Wavestate, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-27
- Decision date
- 2010-06-29
- Days to decision
- 306 days
- Clearance type
- Traditional
- Product code
- ORT
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Crofton, MD, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.