X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)— 510(k) K152040
Substantially EquivalentAdvanced Brain Monitoring, Inc.
FDA 510(k) clearance K152040 for X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29), Substantially Equivalent on 2015-10-30. Applicant: Advanced Brain Monitoring, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Brain Monitoring, Inc.
- Product code
- Code OMC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code OMC
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