BIS SRS (SEMI-RESUABLE SENSOR)— 510(k) K050313
Substantially EquivalentAspect Medical Systems, Inc.
FDA 510(k) clearance K050313 for BIS SRS (SEMI-RESUABLE SENSOR), Substantially Equivalent on 2005-02-24. Applicant: Aspect Medical Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Aspect Medical Systems, Inc.
- Product code
- Code GWY
- Device class
- Class 1
- Regulation
- 21 CFR 882.1750
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newton, MA, US
Recent devices under product code GWY
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