PDH · Blanket, Neonatal Phototherapy
General Hospital · 21 CFR 880.5700 · Class 2
Overview
| Product Code | PDH |
|---|---|
| Device Name | Blanket, Neonatal Phototherapy |
| Regulation | 21 CFR 880.5700 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142416 | Luma Wrap | Salter Labs | Jun 12, 2015 | SESE |
| K123411 | LITTLE ANGELS SWADDLING BLANKET | Bionix Development Corp. | Mar 7, 2013 | SESE |
Top Applicants
- Bionix Development Corp. — 1 clearance
- Salter Labs — 1 clearance
