X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE— 510(k) K131383
Substantially EquivalentAdvanced Brain Monitoring, Inc.
FDA 510(k) clearance K131383 for X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE, Substantially Equivalent on 2013-11-27. Applicant: Advanced Brain Monitoring, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Brain Monitoring, Inc.
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dousman, WI, US
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