The following data is part of a premarket notification filed by Exploramed Nc7, Inc with the FDA for Athena Breast Pump.
| Device ID | K161266 |
| 510k Number | K161266 |
| Device Name: | Athena Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | EXPLORAMED NC7, INC 2639A TERMINAL BLVD Mountain View, CA 94043 |
| Contact | John Chang |
| Correspondent | Keri Ng EXPLORAMED NC7, INC 2639A TERMINAL BLVD Mountain View, CA 94043 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-05 |
| Decision Date | 2016-08-11 |
| Summary: | summary |