AMEDA AMECARE(R) NEONATAL INCUBATOR
Device Facts
| Record ID | K870222 |
|---|---|
| Device Name | AMEDA AMECARE(R) NEONATAL INCUBATOR |
| Applicant | Hollister, Inc. |
| Product Code | FMZ · General Hospital |
| Decision Date | Jun 10, 1987 |
| 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.
