The following data is part of a premarket notification filed by Avent America, Inc. with the FDA for Isis Iq Duo Twin Electronic Breast Pump, Model 100.
| Device ID | K051413 |
| 510k Number | K051413 |
| Device Name: | ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100 |
| Classification | Pump, Breast, Powered |
| Applicant | AVENT AMERICA, INC. 1 SPEEN STREET SUITE 160 Framingham, MA 01701 |
| Contact | Richard Morroney |
| Correspondent | Richard Morroney AVENT AMERICA, INC. 1 SPEEN STREET SUITE 160 Framingham, MA 01701 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-08-29 |
| Summary: | summary |