iSyncWave— 510(k) K220056

Substantially Equivalent

iMediSync, Inc.

FDA 510(k) clearance K220056 for iSyncWave, Substantially Equivalent on 2022-08-10. Applicant: iMediSync, Inc.. Device class: 2.

Clearance details

Applicant: iMediSync, Inc.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2022-01-06
Decision date: 2022-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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