The following data is part of a premarket notification filed by Ardo Medical Ag with the FDA for Ardo Calypso Pro Powered Breast Pump.
| Device ID | K150721 |
| 510k Number | K150721 |
| Device Name: | ARDO Calypso Pro Powered Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | ARDO MEDICAL AG Gewerbestrasse 19 Unteraegeri, CH 6314 |
| Contact | Roger Dubach |
| Correspondent | Yarmela Pavlovic HOGAN LOVELLS US LLP 3 Embarcdero Center, Suite 1500 San Francisco, CA 94111 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-19 |
| Decision Date | 2015-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814079021992 | K150721 | 000 |
| 00814079020919 | K150721 | 000 |
| 00814079020810 | K150721 | 000 |