Sense System with IBT Electrodes— 510(k) K182112
Substantially EquivalentInfinite Biomedical Technologies, LLC
FDA 510(k) clearance K182112 for Sense System with IBT Electrodes, Substantially Equivalent on 2018-10-05. Applicant: Infinite Biomedical Technologies, LLC. Device class: 2.
Clearance details
- Applicant
- Infinite Biomedical Technologies, LLC
- 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
- Baltimore, MD, US
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