TRACOE smart Cuff Manager
K-Number: K152865 · 2016-09-27
ApplicantTracoe Medical GmbH
Decision Date2016-09-27
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
TRACOE smart Cuff Manager is a medical device manufactured by Tracoe Medical GmbH. It received FDA 510(k) clearance on 2016-09-27 under approval number K152865. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRACOE smart Cuff Manager?
TRACOE smart Cuff Manager is a medical device that received FDA 510(k) clearance on 2016-09-27. It is manufactured by Tracoe Medical GmbH. The 510(k) number is K152865.
When was TRACOE smart Cuff Manager approved by the FDA?
TRACOE smart Cuff Manager received FDA 510(k) clearance on 2016-09-27, under approval number K152865.
What company makes TRACOE smart Cuff Manager?
TRACOE smart Cuff Manager is manufactured by Tracoe Medical GmbH.
What is the FDA product code for TRACOE smart Cuff Manager?
The FDA product code for TRACOE smart Cuff Manager is BSK.
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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.