HAMILTON-T1, HAMILTON-C1
K-Number: K181216 · 2019-08-02
ApplicantHamilton Medical AG
Decision Date2019-08-02
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
HAMILTON-T1, HAMILTON-C1 is a medical device manufactured by Hamilton Medical AG. It received FDA 510(k) clearance on 2019-08-02 under approval number K181216. 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-T1, HAMILTON-C1?
HAMILTON-T1, HAMILTON-C1 is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Hamilton Medical AG. The 510(k) number is K181216.
When was HAMILTON-T1, HAMILTON-C1 approved by the FDA?
HAMILTON-T1, HAMILTON-C1 received FDA 510(k) clearance on 2019-08-02, under approval number K181216.
What company makes HAMILTON-T1, HAMILTON-C1?
HAMILTON-T1, HAMILTON-C1 is manufactured by Hamilton Medical AG.
What is the FDA product code for HAMILTON-T1, HAMILTON-C1?
The FDA product code for HAMILTON-T1, HAMILTON-C1 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.