Ohio 3300 Infant Warmer System
510(k) K840858
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840858 | Date23 Mar 1984 | StatusActive |
Recalls
-
- Terminated Z-2323-2017
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5130
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Ohio 3300 Infant Warmer System is an infant radiant warmer designed for use in general hospital settings. It provides controlled warmth for neonates during procedures and care in nursery and labor and delivery environments.
This device is supplied as part of a system and is intended for single-use applications. It is not MRI compatible and requires appropriate storage conditions. The Ohio 3300 Infant Warmer System has FDA 510(k) clearance with product code FMT and is classified as a Class II medical device.