K160238 is an FDA 510(k) clearance for the Airborne Phototherapy Light. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by International Biomedical (Austin, US). The FDA issued a Cleared decision on June 14, 2016, 134 days after receiving the submission on February 1, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K160238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2016 |
| Decision Date | June 14, 2016 |
| Days to Decision | 134 days |
| Submission Type | Abbreviated |
| 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 |