iSyncBrain©-C
K-Number: K222838 · 2023-03-16
ApplicantiMediSync, Inc.
Decision Date2023-03-16
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
iSyncBrain©-C is a medical device manufactured by iMediSync, Inc.. It received FDA 510(k) clearance on 2023-03-16 under approval 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. It is manufactured by iMediSync, Inc.. The 510(k) number is K222838.
When was iSyncBrain©-C approved by the FDA?
iSyncBrain©-C received FDA 510(k) clearance on 2023-03-16, under approval number K222838.
What company makes iSyncBrain©-C?
iSyncBrain©-C is manufactured by iMediSync, Inc..
What is the FDA product code for iSyncBrain©-C?
The FDA product code for iSyncBrain©-C is OLU.
Other Devices by iMediSync, Inc.
Related Devices (Code: OLU)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.