The following data is part of a premarket notification filed by Wipro Ge Healthcare Private, Ltd. with the FDA for Lullaby Tm Warmer.
| Device ID | K121625 |
| 510k Number | K121625 |
| Device Name: | LULLABY TM WARMER |
| Classification | Warmer, Infant Radiant |
| Applicant | WIPRO GE HEALTHCARE PRIVATE, LTD. 8880 GOMAN ROAD Laurel, MD 20723 -5800 |
| Contact | Agata Anthony |
| Correspondent | Agata Anthony WIPRO GE HEALTHCARE PRIVATE, LTD. 8880 GOMAN ROAD Laurel, MD 20723 -5800 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2012-09-14 |
| Summary: | summary |