K071828 is an FDA 510(k) clearance for the LULLABY. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Ge Healthcare Clinical Systems (Laurel, US). The FDA issued a Cleared decision on August 6, 2007, 34 days after receiving the submission on July 3, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K071828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2007 |
| Decision Date | August 06, 2007 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LBI — Unit, Neonatal Phototherapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5700 |