LIFE TRACE(R) BILIRUBIN MASK
Device Facts
| Record ID | K926118 |
|---|---|
| Device Name | LIFE TRACE(R) BILIRUBIN MASK |
| Applicant | Graphic Controls Corp. |
| Product Code | FOK · General Hospital |
| Decision Date | Mar 15, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5270 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.
