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FDA 510(k)

Hamilton-G5

K-Number: K180295 · 2019-07-30

ApplicantHamiton Medical AG
Decision Date2019-07-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hamilton-G5 is a medical device manufactured by Hamiton Medical AG. It received FDA 510(k) clearance on 2019-07-30 under approval number K180295. 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-G5?

Hamilton-G5 is a medical device that received FDA 510(k) clearance on 2019-07-30. It is manufactured by Hamiton Medical AG. The 510(k) number is K180295.

When was Hamilton-G5 approved by the FDA?

Hamilton-G5 received FDA 510(k) clearance on 2019-07-30, under approval number K180295.

What company makes Hamilton-G5?

Hamilton-G5 is manufactured by Hamiton Medical AG.

What is the FDA product code for Hamilton-G5?

The FDA product code for Hamilton-G5 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.

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