BIS EEG MONITOR, MODEL BISX4— 510(k) K052981
Substantially EquivalentAspect Medical Systems, Inc.
FDA 510(k) clearance K052981 for BIS EEG MONITOR, MODEL BISX4, Substantially Equivalent on 2005-11-01. Applicant: Aspect Medical Systems, Inc..
Clearance details
- Applicant
- Aspect Medical Systems, Inc.
- Product code
- Code OLW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newton, MA, US
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