The following data is part of a premarket notification filed by Montrose Phototherapy Supply with the FDA for Infant Phototherapy Mask.
| Device ID | K813214 |
| 510k Number | K813214 |
| Device Name: | INFANT PHOTOTHERAPY MASK |
| Classification | Pad, Neonatal Eye |
| Applicant | MONTROSE PHOTOTHERAPY SUPPLY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FOK |
| CFR Regulation Number | 880.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-09 |
| Decision Date | 1981-12-09 |