K111547 is an FDA 510(k) clearance for the BILI-THERAPY PAD TYPE. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Atom Medical Corporation (Bonita Springs, US). The FDA issued a Cleared decision on April 12, 2012, 314 days after receiving the submission on June 3, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K111547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2011 |
| Decision Date | April 12, 2012 |
| Days to Decision | 314 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 |