The following data is part of a premarket notification filed by Connexall Usa, Inc. with the FDA for Connexall Suite Of Software Products.
| Device ID | K112650 |
| 510k Number | K112650 |
| Device Name: | CONNEXALL SUITE OF SOFTWARE PRODUCTS |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | CONNEXALL USA, INC. PO BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke CONNEXALL USA, INC. PO BOX 3018 Nederland, CO 80466 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-12 |
| Decision Date | 2012-02-01 |
| Summary: | summary |