FDA 510(k)

iSyncBrain©-C

K-Number: K222838 · 2023-03-16

Decision Date2023-03-16

Product CodeOLU

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

iSyncBrain©-C is the device name listed in this FDA 510(k) record. The listed applicant is iMediSync, Inc.. It received FDA 510(k) clearance on 2023-03-16 under 510(k) number K222838. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iSyncBrain©-C?

iSyncBrain©-C is a medical device that received FDA 510(k) clearance on 2023-03-16. The listed applicant is iMediSync, Inc.. The 510(k) number is K222838.

When did iSyncBrain©-C receive FDA 510(k) clearance?

iSyncBrain©-C received FDA 510(k) clearance on 2023-03-16, under 510(k) number K222838.

Who is the listed applicant for iSyncBrain©-C?

The FDA 510(k) record lists iMediSync, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSyncBrain©-C?

The FDA product code for iSyncBrain©-C is OLU.

Other records listing iMediSync, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220056iSyncWave

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.