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 |