IntelliCuff
K-Number: K150893 · 2016-01-29
ApplicantHamilton Medical AG
Decision Date2016-01-29
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
IntelliCuff is a medical device manufactured by Hamilton Medical AG. It received FDA 510(k) clearance on 2016-01-29 under approval number K150893. 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 IntelliCuff?
IntelliCuff is a medical device that received FDA 510(k) clearance on 2016-01-29. It is manufactured by Hamilton Medical AG. The 510(k) number is K150893.
When was IntelliCuff approved by the FDA?
IntelliCuff received FDA 510(k) clearance on 2016-01-29, under approval number K150893.
What company makes IntelliCuff?
IntelliCuff is manufactured by Hamilton Medical AG.
What is the FDA product code for IntelliCuff?
The FDA product code for IntelliCuff is BSK.
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K173914VORTRAN Cuff Inflator (VCI)Vortran Medical Technology 1, Inc.
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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.