K203383 is an FDA 510(k) clearance for the Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62. This device is classified as a Pump, Breast, Powered (Class II - Special Controls, product code HGX).
Submitted by Philips Consumer Lifestyle - Innovation Site Eindhoven (Eindhoven, NL). The FDA issued a Cleared decision on December 15, 2020, 28 days after receiving the submission on November 17, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5160.
| 510(k) Number | K203383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2020 |
| Decision Date | December 15, 2020 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |