iSyncBrain©-C— 510(k) K222838

Substantially Equivalent

iMediSync, Inc.

FDA 510(k) clearance K222838 for iSyncBrain©-C, Substantially Equivalent on 2023-03-16. Applicant: iMediSync, Inc.. Device class: 2.

Clearance details

Applicant: iMediSync, Inc.
Product code: Code OLU
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2022-09-20
Decision date: 2023-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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More clearances from iMediSync, Inc.

K220056 — iSyncWave2022-08-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.