DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
Device Facts
| Record ID | K962290 |
|---|---|
| Device Name | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER |
| Applicant | Debusk Technology Corp. |
| Product Code | FOK · General Hospital |
| Decision Date | Jul 3, 1996 |
| 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.
