The following data is part of a premarket notification filed by Carematix Inc. with the FDA for Modification To Carematix Wellness System.
| Device ID | K040966 |
| 510k Number | K040966 |
| Device Name: | MODIFICATION TO CAREMATIX WELLNESS SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | CAREMATIX INC. 2 N. LASALLE ST. SUITE 1805 Chicago, IL 60602 |
| Contact | Sukhwant Khanuja |
| Correspondent | Sukhwant Khanuja CAREMATIX INC. 2 N. LASALLE ST. SUITE 1805 Chicago, IL 60602 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-14 |
| Decision Date | 2004-06-02 |
| Summary: | summary |