CENTRA VIEW DEVICE LINK SYSTEM

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

ICU DATASYSTEMS, INC.

The following data is part of a premarket notification filed by Icu Datasystems, Inc. with the FDA for Centra View Device Link System.

Pre-market Notification Details

Device IDK033283
510k NumberK033283
Device Name:CENTRA VIEW DEVICE LINK SYSTEM
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant ICU DATASYSTEMS, INC. 2153 SE HAWTHORNE ROAD SUITE 220 Gainesville,  FL  32641
ContactSamuel W Coons
CorrespondentGeorge Kreiner
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-10-14
Decision Date2003-10-27
Summary:summary

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