The following data is part of a premarket notification filed by Amcom Software,inc. with the FDA for Amcom Commtech Messenger.
Device ID | K112047 |
510k Number | K112047 |
Device Name: | AMCOM COMMTECH MESSENGER |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | AMCOM SOFTWARE,INC. PO BOX 3018 Nederland, CO 80466 |
Contact | Thomas Kroenke |
Correspondent | Thomas Kroenke AMCOM SOFTWARE,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 | 2011-07-18 |
Decision Date | 2011-09-13 |
Summary: | summary |