K020518 is an FDA 510(k) clearance for the MEDELA SYMPHONY BREAST PUMP, MODEL 024. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Medela, Inc. (Baar, Zug,, CH). The FDA issued a Cleared decision on March 7, 2002, 16 days after receiving the submission on February 19, 2002.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K020518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2002 |
| Decision Date | March 07, 2002 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGX — Pump, Breast, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5160 |