The following data is part of a premarket notification filed by Dao Health with the FDA for Freemie (r).
| Device ID | K111411 |
| 510k Number | K111411 |
| Device Name: | FREEMIE (R) |
| Classification | Pump, Breast, Powered |
| Applicant | DAO HEALTH 2526 Capitol Avenue Sacramento, CA 95816 |
| Contact | Dan Garbez |
| Correspondent | Dan Garbez DAO HEALTH 2526 Capitol Avenue Sacramento, CA 95816 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-20 |
| Decision Date | 2012-02-01 |
| Summary: | summary |