K984589 is an FDA 510(k) clearance for the PHOTOTHERAPY LAMP. This device is classified as a Unit, Neonatal Phototherapy (Class II - Special Controls, product code LBI).
Submitted by Medela, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 20, 1999, 117 days after receiving the submission on December 24, 1998.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5700.
| 510(k) Number | K984589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1998 |
| Decision Date | April 20, 1999 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LBI — Unit, Neonatal Phototherapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5700 |