Identifiers
- 510(k) Number
- K971366 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)
An infant radiant warmer is a device that provides radiant heat to maintain the body temperature of newborn infants. It is used in general hospital settings to support thermoregulation in neonatal care.
The device is supplied as a reusable system and was cleared through the FDA 510(k) process under K971366 with a traditional clearance. It is classified as a Class II medical device under regulation number 880.5130 and is authorized for use in general hospital environments.
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 K971366 - Incuwarmer
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971366 | Class II | Active |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
Sources (1)
- FDA 510(k) K971366 24 fields · synced Sep 24, 2026