The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Duo-lite Phototherapy System.
| Device ID | K971256 |
| 510k Number | K971256 |
| Device Name: | DUO-LITE PHOTOTHERAPY SYSTEM |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | Marci L Goldfinger |
| Correspondent | Marci L Goldfinger AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-04 |
| Decision Date | 1997-09-24 |
| Summary: | summary |