ATOM INFA WARMER V-505
Device Facts
| Record ID | K002355 |
|---|---|
| Device Name | ATOM INFA WARMER V-505 |
| Applicant | Atom Medical Corp |
| Product Code | FMT · General Hospital |
| Decision Date | Oct 10, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 880.5130 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.
Special Controls
*Classification.* Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer; (2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and (3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
