The following data is part of a premarket notification filed by Carematix Inc. with the FDA for Carematix Wellness System.
| Device ID | K031840 |
| 510k Number | K031840 |
| Device Name: | CAREMATIX WELLNESS SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CAREMATIX INC. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm CAREMATIX INC. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-16 |
| Decision Date | 2003-10-10 |
| Summary: | summary |