The following data is part of a premarket notification filed by Hygeia Ii Medical Group, Inc. with the FDA for Evolve Breast Pump.
| Device ID | K190465 |
| 510k Number | K190465 |
| Device Name: | Evolve Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Hygeia II Medical Group, Inc. 6241 Yarrow Drive Carlsbad, CA 92011 |
| Contact | Brett Nakfoor |
| Correspondent | Brett Nakfoor Hygeia II Medical Group, Inc. 6241 Yarrow Drive Carlsbad, CA 92011 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-26 |
| Decision Date | 2019-10-18 |