APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600— 510(k) K071230
Substantially EquivalentAdvanced Brain Monitoring, Inc.
FDA 510(k) clearance K071230 for APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600, Substantially Equivalent on 2007-10-03. Applicant: Advanced Brain Monitoring, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Brain Monitoring, Inc.
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Carlsbad, CA, US
Recent devices under product code MNR
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