Critical Alert CommonPath Enterprise

System, Network And Communication, Physiological Monitors

Critical Alert

The following data is part of a premarket notification filed by Critical Alert with the FDA for Critical Alert Commonpath Enterprise.

Pre-market Notification Details

Device IDK193043
510k NumberK193043
Device Name:Critical Alert CommonPath Enterprise
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant Critical Alert 4901 Belfort Road, Suite 130 Jacksonville,  FL  32256
ContactJohn Elms
CorrespondentThomas Kroenke
Speed To Market, Inc. PO Box 3018 Nederland,  CO  80466
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-31
Decision Date2020-05-11

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