The following data is part of a premarket notification filed by Philips Consumer Lifestyle - Innovation Site Eindhoven with the FDA for Philips Avent Single/double Electric Breast Pump Advanced.
| Device ID | K201381 |
| 510k Number | K201381 |
| Device Name: | Philips Avent Single/Double Electric Breast Pump Advanced |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-26 |
| Decision Date | 2020-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075020091505 | K201381 | 000 |
| 00075020091499 | K201381 | 000 |
| 00075020091482 | K201381 | 000 |
| 00075020089731 | K201381 | 000 |
| 00075020089724 | K201381 | 000 |
| 00075020086655 | K201381 | 000 |