OMNI INFANT PHOTOTHERAPY UNIT
Device Facts
| Record ID | K834430 |
|---|---|
| Device Name | OMNI INFANT PHOTOTHERAPY UNIT |
| Applicant | Rocky Mountain Medical Corp. |
| Product Code | LBI · General Hospital |
| Decision Date | Apr 30, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.
