The following data is part of a premarket notification filed by Philips Consumer Lifestyle - Innovation Site Eindhoven with the FDA for Philips Avent Double Electric Breast Pump Advanced Scf394/61, Philips Avent Double Electric Breast Pump Advanced Scf394/62.
| Device ID | K203383 |
| 510k Number | K203383 |
| Device Name: | Philips Avent Double Electric Breast Pump Advanced SCF394/61, Philips Avent Double Electric Breast Pump Advanced SCF394/62 |
| Classification | Pump, Breast, Powered |
| Applicant | Philips Consumer Lifestyle - Innovation Site Eindhoven High Tech Campus 37 Eindhoven, NL 5656 Ae |
| Contact | Aurore Millet |
| Correspondent | Aurore Millet Philips Consumer Lifestyle - Innovation Site Eindhoven High Tech Campus 37 Eindhoven, NL 5656 Ae |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-17 |
| Decision Date | 2020-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075020091512 | K203383 | 000 |
| 00075020086662 | K203383 | 000 |
| 00075020104052 | K203383 | 000 |
| 00075020104045 | K203383 | 000 |
| 00075020107770 | K203383 | 000 |