The following data is part of a premarket notification filed by Ascom (us), Inc. with the FDA for Ascom Clinicalconnex Cardiomax.
Device ID | K103634 |
510k Number | K103634 |
Device Name: | ASCOM CLINICALCONNEX CARDIOMAX |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | ASCOM (US), INC. PO BOX 3018 Nederland, CO 80466 |
Contact | Thomas Kroenke |
Correspondent | Thomas Kroenke ASCOM (US), 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 | 2010-12-13 |
Decision Date | 2011-02-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17350088670016 | K103634 | 000 |