iSyncBrain©-C
FDA 510(k) clearance K222838 · decided 2023-03-16
Clearance details
- K-number
- K222838
- Device name
- iSyncBrain©-C
- Applicant
- iMediSync, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-20
- Decision date
- 2023-03-16
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- OLU
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.