The following data is part of a premarket notification filed by Medela Llc with the FDA for Solo, Swing Maxi.
| Device ID | K210759 |
| 510k Number | K210759 |
| Device Name: | Solo, Swing Maxi |
| Classification | Pump, Breast, Powered |
| Applicant | Medela LLC 1101 Corporate Drive Mchenry, IL 60050 |
| Contact | Mike Mcandrew |
| Correspondent | Jenni Vescovo Medela AG Laettichstrasse 4b Baar, CH 6340 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00020451436142 | K210759 | 000 |
| 07612367078160 | K210759 | 000 |