The following data is part of a premarket notification filed by Wipro Ge Healthcare Private, Ltd. with the FDA for Lullaby Led Phottherapy System.
| Device ID | K120168 |
| 510k Number | K120168 |
| Device Name: | LULLABY LED PHOTTHERAPY SYSTEM |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | WIPRO GE HEALTHCARE PRIVATE, LTD. 8880 GORMAN ROAD Laurel, MD 20723 |
| Contact | Agata Anthony |
| Correspondent | Agata Anthony WIPRO GE HEALTHCARE PRIVATE, LTD. 8880 GORMAN ROAD Laurel, MD 20723 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-19 |
| Decision Date | 2012-05-02 |
| Summary: | summary |