HAMILTON-MR1
K-Number: K153046 · 2016-09-06
ApplicantHamilton Medical AG
Decision Date2016-09-06
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
HAMILTON-MR1 is a medical device manufactured by Hamilton Medical AG. It received FDA 510(k) clearance on 2016-09-06 under approval number K153046. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HAMILTON-MR1?
HAMILTON-MR1 is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Hamilton Medical AG. The 510(k) number is K153046.
When was HAMILTON-MR1 approved by the FDA?
HAMILTON-MR1 received FDA 510(k) clearance on 2016-09-06, under approval number K153046.
What company makes HAMILTON-MR1?
HAMILTON-MR1 is manufactured by Hamilton Medical AG.
What is the FDA product code for HAMILTON-MR1?
The FDA product code for HAMILTON-MR1 is CBK.
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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.