The following data is part of a premarket notification filed by Dao Health with the FDA for Freemie Independence, Freemie Liberty.
| Device ID | K172772 |
| 510k Number | K172772 |
| Device Name: | Freemie Independence, Freemie Liberty |
| Classification | Pump, Breast, Powered |
| Applicant | DAO Health 1345 Easy Lane El Dorado Hills, CA 95762 |
| Contact | Dave Paul |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-09-14 |
| Decision Date | 2017-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885131690880 | K172772 | 000 |
| 10851690007957 | K172772 | 000 |
| 10851690007964 | K172772 | 000 |
| 10851690007438 | K172772 | 000 |
| 00851690007448 | K172772 | 000 |
| 10851690007452 | K172772 | 000 |
| 10851690007520 | K172772 | 000 |
| 10851690007865 | K172772 | 000 |
| 10851690007889 | K172772 | 000 |
| 10851690007896 | K172772 | 000 |
| 10851690007902 | K172772 | 000 |