The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medela Electric Breast Pump.
| Device ID | K801862 |
| 510k Number | K801862 |
| Device Name: | MEDELA ELECTRIC BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | MEDELA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-05 |
| Decision Date | 1980-10-23 |