The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Phototherapy Unit 7850 Neonatal Photo.
| Device ID | K840454 |
| 510k Number | K840454 |
| Device Name: | PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | AIR-SHIELDS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-23 |
| Decision Date | 1984-03-23 |