The following data is part of a premarket notification filed by Ardo Medical Ag with the FDA for One Mum Pumpset.
| Device ID | K172067 |
| 510k Number | K172067 |
| Device Name: | One Mum Pumpset |
| Classification | Pump, Breast, Powered |
| Applicant | Ardo Medical AG Gewerbestrasse 19 Unterageri, CH 6314 |
| Contact | Roger Dubach |
| Correspondent | Yarmela Pavlovic Hogan Lovells US LLP 3 Embarcadero Center, Suite 1500 San Francisco, CA 94111 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-07 |
| Decision Date | 2017-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814079021657 | K172067 | 000 |
| 00814079021541 | K172067 | 000 |