HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
K-Number: K163283 · 2017-09-20
ApplicantHamilton Medical AG
Decision Date2017-09-20
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is a medical device manufactured by Hamilton Medical AG. It received FDA 510(k) clearance on 2017-09-20 under approval number K163283. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is a medical device that received FDA 510(k) clearance on 2017-09-20. It is manufactured by Hamilton Medical AG. The 510(k) number is K163283.
When was HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 approved by the FDA?
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 received FDA 510(k) clearance on 2017-09-20, under approval number K163283.
What company makes HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is manufactured by Hamilton Medical AG.
What is the FDA product code for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?
The FDA product code for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is BTT.
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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.