MODEL TI500 ISOLETTE INFANT INCUBATOR
Device Facts
| Record ID | K941106 |
|---|---|
| Device Name | MODEL TI500 ISOLETTE INFANT INCUBATOR |
| Applicant | Air-Shields, Inc. |
| Product Code | FPL · General Hospital |
| Decision Date | Jun 10, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5410 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.
