The following data is part of a premarket notification filed by Philips Consumer Lifestyle-innovation Site Eindhoven with the FDA for Philips Avent Comfort Single/twin Electric Breast Pump.
| Device ID | K161532 |
| 510k Number | K161532 |
| Device Name: | Philips Avent Comfort Single/Twin Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Philips Consumer Lifestyle-Innovation Site Eindhoven High Tech Campus 37 Eindhoven, NL 5656 Ae |
| Contact | Marta Walker |
| Correspondent | Marta Walker 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 | 2016-06-02 |
| Decision Date | 2016-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075020070111 | K161532 | 000 |
| 00075020070104 | K161532 | 000 |
| 00075020070098 | K161532 | 000 |
| 00075020070081 | K161532 | 000 |
| 00075020070074 | K161532 | 000 |