The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Model 533 Phototherapy Unit.
| Device ID | K810953 |
| 510k Number | K810953 |
| Device Name: | MODEL 533 PHOTOTHERAPY UNIT |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | NARCO AIR-SHIELDS 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 | 1981-04-07 |
| Decision Date | 1981-04-23 |