GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)— 510(k) K062580
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K062580 for GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784), Substantially Equivalent on 2007-12-21. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- 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
- Needham, MA, US
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More clearances from GE Healthcare
view allData sourced from openFDA. This site is unofficial and independent of the FDA.