The following data is part of a premarket notification filed by Alba Health Care with the FDA for Infant Phototherapy Mask.
| Device ID | K851918 |
| 510k Number | K851918 |
| Device Name: | INFANT PHOTOTHERAPY MASK |
| Classification | Pad, Neonatal Eye |
| Applicant | ALBA HEALTH CARE POST OFFICE BOX 100 Valdese, NC 28690 |
| Contact | Victor H Garrou |
| Correspondent | Victor H Garrou ALBA HEALTH CARE POST OFFICE BOX 100 Valdese, NC 28690 |
| Product Code | FOK |
| CFR Regulation Number | 880.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-02 |
| Decision Date | 1985-06-07 |