Brainsway Deep TMS System
K-Number: K183303 · 2019-03-08
ApplicantBrainsway , Ltd.
Decision Date2019-03-08
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Brainsway Deep TMS System is a medical device manufactured by Brainsway , Ltd.. It received FDA 510(k) clearance on 2019-03-08 under approval number K183303. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Brainsway Deep TMS System?
Brainsway Deep TMS System is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Brainsway , Ltd.. The 510(k) number is K183303.
When was Brainsway Deep TMS System approved by the FDA?
Brainsway Deep TMS System received FDA 510(k) clearance on 2019-03-08, under approval number K183303.
What company makes Brainsway Deep TMS System?
Brainsway Deep TMS System is manufactured by Brainsway , Ltd..
What is the FDA product code for Brainsway Deep TMS System?
The FDA product code for Brainsway Deep TMS System is QCI.
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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.