The following data is part of a premarket notification filed by Medela Ag with the FDA for Medela Swing Breast Pump.
| Device ID | K053052 |
| 510k Number | K053052 |
| Device Name: | MEDELA SWING BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA AG LAETTICHSTRASSE 4B Baar, Zug, CH Ch-6341 |
| Contact | Wemer Frei |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-31 |
| Decision Date | 2006-05-02 |
| Summary: | summary |