BIS ENGINE— 510(k) K011834
Substantially EquivalentAspect Medical Systems, Inc.
FDA 510(k) clearance K011834 for BIS ENGINE, Substantially Equivalent on 2001-07-10. 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.