iCEWav Neuromonitoring Platform— 510(k) K191868
Substantially EquivalentIce Neurosystems, Inc.
FDA 510(k) clearance K191868 for iCEWav Neuromonitoring Platform, Substantially Equivalent on 2020-03-31. Applicant: Ice Neurosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Ice Neurosystems, Inc.
- 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
- Washington, DC, US
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