The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Neonate Mask For Babies.
| Device ID | K840444 |
| 510k Number | K840444 |
| Device Name: | NEONATE MASK FOR BABIES |
| Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Applicant | RICHARDS MEDICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HOY |
| CFR Regulation Number | 886.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-01 |
| Decision Date | 1984-03-16 |