INFANT PHOTOTHERAPY MASK
Device Facts
| Record ID | K813214 |
|---|---|
| Device Name | INFANT PHOTOTHERAPY MASK |
| Applicant | Montrose Phototherapy Supply |
| Product Code | FOK · General Hospital |
| Decision Date | Dec 9, 1981 |
| 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.
