510(k) K222838
K222838 is an FDA 510(k) premarket notification submitted by iMediSync, Inc. for the device "iSyncBrain©-C". The FDA issued a decision of Substantially Equivalent on March 16, 2023. The device falls under product code OLU (Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. iMediSync, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2023
- Date Received
- September 20, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Normalizing Quantitative Electroencephalograph Software
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.