The following data is part of a premarket notification filed by Ardo Medical Ag with the FDA for Ardo Alyssa.
| Device ID | K212773 |
| 510k Number | K212773 |
| Device Name: | ARDO Alyssa |
| Classification | Pump, Breast, Powered |
| Applicant | ARDO Medical AG Gewerbestrasse 19 Unteraegeri, CH 6314 |
| Contact | Thomas Schlieper |
| Correspondent | Kristin Zielinski Duggan Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-31 |
| Decision Date | 2022-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640108053541 | K212773 | 000 |
| 07640108053640 | K212773 | 000 |
| 07640108053961 | K212773 | 000 |
| 07640108054470 | K212773 | 000 |