← Back to catalogue

HAMILTON-G5

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131774

by Hamilton Medical AG

Identifiers

510(k) Number
K131774 FDA 510(k)
FDA Product Code
CBK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5895 FDA 510(k)
Regulation Number
868.5895 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hamilton-G5 is a Ventilator, Continuous, Facility Use, classified as a device class 2. It is used in the medical specialty of Anesthesiology.

The Hamilton-G5 is supplied with various registration numbers, including 1218058, 3010017366, and others. It is regulated under the regulation number 868.5895 and has been cleared with a Traditional clearance type, with a decision code of SESE, indicating it is substantially equivalent. The device has an FDA 510K authorization.

Frequently asked questions

What is the Hamilton-G5 used for?

The Hamilton-G5 is used in the medical specialty of Anesthesiology as a continuous ventilator for facility use.

What type of clearance does the Hamilton-G5 have?

The Hamilton-G5 has been cleared with a Traditional 510K authorization, indicating it is substantially equivalent to a predicate device.

What is the regulation number for the Hamilton-G5?

The Hamilton-G5 is regulated under the regulation number 868.5895.

What is the device class of the Hamilton-G5?

The Hamilton-G5 is classified as a device class 2.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hamilton Medical AG

Sources (1)

  • FDA 510(k) K131774 24 fields · synced Sep 23, 2026