EEG-Now— 510(k) K180524
Substantially EquivalentEncephalodynamics, Inc.
FDA 510(k) clearance K180524 for EEG-Now, Substantially Equivalent on 2018-05-18. Applicant: Encephalodynamics, Inc.. Device class: 2.
Clearance details
- Applicant
- Encephalodynamics, 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
- Gainesville, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.