ISOLETTE INFANT INCUBATOR, MODEL C2HS
Device Facts
| Record ID | K001242 |
|---|---|
| Device Name | ISOLETTE INFANT INCUBATOR, MODEL C2HS |
| Applicant | Hill-Rom Air-Shields |
| Product Code | FMZ · General Hospital |
| Decision Date | Jul 13, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.
