K210289 is an FDA 510(k) clearance for the Infant Phototherapy Equipment. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Bistos Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on May 28, 2021, 115 days after receiving the submission on February 2, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K210289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2021 |
| Decision Date | May 28, 2021 |
| Days to Decision | 115 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 |