System, Network And Communication, Physiological Monitors

AlertWatch, Inc.

The following data is part of a premarket notification filed by Alertwatch, Inc. with the FDA for Alertwatch:ac.

Pre-market Notification Details

Device IDK210160
510k NumberK210160
Device Name:AlertWatch:AC
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant AlertWatch, Inc. 330 East Liberty St., Fourth Floor Ann Arbor,  MI  48104
ContactJustin Adams
CorrespondentDonna-bea Tillman
Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-21
Decision Date2021-09-10

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