Identifiers
- 510(k) Number
- K201306 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-C3 is a continuous ventilator intended for facility use. It is designed to provide mechanical ventilation support to patients.
This device is authorized under FDA 510K clearance. It is categorized under the anesthesiology medical specialty.
Frequently asked questions
What is the primary purpose of the Hamilton-C3?
The Hamilton-C3 is a continuous ventilator intended for use in medical facilities to provide mechanical ventilation support to patients.
What is the regulatory status of this device?
The Hamilton-C3 is authorized under FDA 510K clearance, which indicates that the device has been found to be substantially equivalent to other legally marketed devices.
Which medical specialty is this ventilator associated with?
The device is categorized under the anesthesiology medical specialty, as indicated by its regulatory filing and advisory committee classification.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201306 | Class II | Active |
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Manufacturer
- Manufacturer
- Hamilton Medical AG
Sources (1)
- FDA 510(k) K201306 24 fields · synced Sep 23, 2026