| Device |
radiant infant warmer cabinet |
| Regulation Description |
Infant radiant warmer. |
| Definition |
The device is intended to provide an enclosure for storage of an radiant infant warmer. It may also provide a bassinet for use with the radiant infant warmer, and provide power to the infant radiant warmer. |
| Physical State |
The accessory could be in a range of sizs and materials. The important aspects are its capability of providing suppport as a bassinet and electrical safety. |
| Technical Method |
When not in use, the device encloses the infant radiant warmer. The device opens to provide a bassinet placed under the warmer. The device includes a power outlet that provides power to the warmer and includes a cut-off switch to disconnect power when the accessory device is closed. |
| Target Area |
The accessory is intended for use with an infant radiant warmer, which are intended for use in warming the whole body of an infant. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | ONM |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5130
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
