K113206 is an FDA 510(k) clearance for the NANOBLUTM 500. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on February 17, 2012, 108 days after receiving the submission on November 1, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K113206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2011 |
| Decision Date | February 17, 2012 |
| Days to Decision | 108 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 |