K200031 is an FDA 510(k) clearance for the Neonatal Phototherapy System. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Avalon Biomedical (Shenzhen) Limited (Longhua District, CN). The FDA issued a Cleared decision on October 5, 2020, 272 days after receiving the submission on January 7, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K200031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2020 |
| Decision Date | October 05, 2020 |
| Days to Decision | 272 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 |