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 |