ENTROPY EASYFIT SENSOR— 510(k) K103129
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K103129 for ENTROPY EASYFIT SENSOR, Substantially Equivalent on 2011-07-19. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Needham, MA, US
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