APNEA RISK EVALUATION SYSTEM (ARES)— 510(k) K112514
Substantially EquivalentAdvanced Brain Monitoring, Inc.
FDA 510(k) clearance K112514 for APNEA RISK EVALUATION SYSTEM (ARES), Substantially Equivalent on 2012-01-09. 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
- Traditional
- Location
- Waukesha, WI, US
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