Identifiers
- 510(k) Number
- K120642 FDA 510(k)
- FDA Product Code
- FMT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5130 FDA 510(k)
- Regulation Number
- 880.5130 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Resuscitaire With Autobreath is an infant radiant warmer designed to provide thermal support for newborns during resuscitation procedures. It features an autobreath function to assist with ventilation during critical care situations.
This device is supplied for use in general hospital settings and is classified as a Class II medical device. It is not specified as single-use or reusable, and no information regarding MRI safety, sizes, or storage conditions is provided in the data.
Frequently asked questions
What is the Resuscitaire With Autobreath used for?
The Resuscitaire With Autobreath is an infant radiant warmer designed to provide thermal support for newborns during resuscitation procedures. It features an autobreath function to assist with ventilation during critical care situations in general hospital settings.
Is the Resuscitaire With Autobreath single-use or reusable?
The device data does not specify whether the Resuscitaire With Autobreath is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.
What is the regulatory classification of the Resuscitaire With Autobreath?
The Resuscitaire With Autobreath is classified as a Class II medical device and received FDA 510(k) clearance with the K number K120642 on November 2, 2012, after being determined substantially equivalent to predicate devices.
What sizes or models of the Resuscitaire With Autobreath are available?
The device data does not provide information about available sizes or models of the Resuscitaire With Autobreath. Specific model details would need to be obtained from the manufacturer or product documentation.
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: RepVisit — Field-Force Management for Medical Representatives
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120642 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA 510(k) K120642 24 fields · synced Oct 6, 2026