← Back to catalogue

Raphael Color

FDA 510(k)

Class II (US FDA 510(k))

510(k) K052863

by Hamilton Medical AG

Identifiers

510(k) Number
K052863 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 RAPHAEL COLOR is a continuous ventilator designed for ventilation of adult and pediatric patients weighing between 5 and 200 kg. It is intended for use by properly trained personnel under direct supervision. The device offers several additional monitoring features and allows data to be displayed as a dynamic loop.

The RAPHAEL COLOR is a Class II device with FDA 510(k) clearance (K052863) and product code CBK. It is manufactured by Hamilton Medical AG and is intended for facility use. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

Frequently asked questions

What is the RAPHAEL COLOR ventilator designed for?

The RAPHAEL COLOR is a continuous ventilator designed for ventilation of adult and pediatric patients weighing between 5 and 200 kg. It is intended for use by properly trained personnel under direct supervision.

What monitoring features does the RAPHAEL COLOR offer?

The RAPHAEL COLOR ventilator offers several additional monitoring features and allows data to be displayed as a dynamic loop, providing clinicians with real-time visualization of patient ventilation parameters.

Is the RAPHAEL COLOR specified as single-use or reusable?

The device is not specified as single-use or reusable in the provided information. Users should consult the manufacturer's instructions for specific guidance on device usage and reprocessing protocols.

What is the regulatory status of the RAPHAEL COLOR?

The RAPHAEL COLOR is a Class II device with FDA 510(k) clearance (K052863) and product code CBK. It is manufactured by Hamilton Medical AG and is intended for facility use.

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. Sources consulted: PDF RAPHAEL Operator's Manual SW 3 - Hamilton Medical, RAPHAEL COLOR ASV VENTILATOR by HAMILTON MEDICAL AG | FDA 510 (k) Summary, RAPHAEL training | Hamilton Medical, RAPHAEL COLOR 510(k) K052863 - FDA.report

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) K052863 24 fields · synced Sep 26, 2026