ASCOM CLINICALCONNEX CARDIOMAX

System, Network And Communication, Physiological Monitors

ASCOM (US), INC.

The following data is part of a premarket notification filed by Ascom (us), Inc. with the FDA for Ascom Clinicalconnex Cardiomax.

Pre-market Notification Details

Device IDK103634
510k NumberK103634
Device Name:ASCOM CLINICALCONNEX CARDIOMAX
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant ASCOM (US), INC. PO BOX 3018 Nederland,  CO  80466
ContactThomas Kroenke
CorrespondentThomas Kroenke
ASCOM (US), INC. PO BOX 3018 Nederland,  CO  80466
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-13
Decision Date2011-02-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17350088670016 K103634 000

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