K161725 is an FDA 510(k) clearance for the Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Medela, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 2016, 128 days after receiving the submission on June 22, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K161725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2016 |
| Decision Date | October 28, 2016 |
| Days to Decision | 128 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 |