The following data is part of a premarket notification filed by Zoe Medical, Inc. with the FDA for Well@home System.
| Device ID | K040012 |
| 510k Number | K040012 |
| Device Name: | WELL@HOME SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ZOE MEDICAL, INC. 460 BOSTON ST. Topsfield, MA 01983 -1223 |
| Contact | Stephen Staats |
| Correspondent | Stephen Staats ZOE MEDICAL, INC. 460 BOSTON ST. Topsfield, MA 01983 -1223 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-05 |
| Decision Date | 2004-04-02 |
| Summary: | summary |