ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110— 510(k) K001980
Substantially EquivalentAspect Medical Systems, Inc.
FDA 510(k) clearance K001980 for ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110, Substantially Equivalent on 2000-09-27. Applicant: Aspect Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Aspect Medical Systems, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newton, MA, US
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More clearances from Aspect Medical Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.