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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 the device name listed in this FDA 510(k) record. The listed applicant is Hamiton Medical AG. It received FDA 510(k) clearance on 2019-07-30 under 510(k) 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. The listed applicant is Hamiton Medical AG. The 510(k) number is K180295.

When did Hamilton-G5 receive FDA 510(k) clearance?

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

Who is the listed applicant for Hamilton-G5?

The FDA 510(k) record lists Hamiton Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hamilton-G5?

The FDA product code for Hamilton-G5 is CBK.

Related Devices (Code: CBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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