Smart Alarm Interface

System, Network And Communication, Physiological Monitors

BoxView, LLC

The following data is part of a premarket notification filed by Boxview, Llc with the FDA for Smart Alarm Interface.

Pre-market Notification Details

Device IDK193421
510k NumberK193421
Device Name:Smart Alarm Interface
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant BoxView, LLC 14001 McAuley Blvd. Suite 220 Oklahoma City,  OK  73134
ContactCody Guest
CorrespondentRobert Steurer
Steurer Consulting Group 800 Blue Quail Rd. Keller,  TX  76248
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-09
Decision Date2020-10-30

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