VENTLINK SYSTEM

Accessory To Continuous Ventilator (respirator)

MEDISERVE INFORMATION SYSTEMS, INC.

The following data is part of a premarket notification filed by Mediserve Information Systems, Inc. with the FDA for Ventlink System.

Pre-market Notification Details

Device IDK052751
510k NumberK052751
Device Name:VENTLINK SYSTEM
ClassificationAccessory To Continuous Ventilator (respirator)
Applicant MEDISERVE INFORMATION SYSTEMS, INC. 3225 S. HARDY DR., SUITE 101 Tempe,  AZ  85282
ContactMark Ofori-kyei
CorrespondentMark Ofori-kyei
MEDISERVE INFORMATION SYSTEMS, INC. 3225 S. HARDY DR., SUITE 101 Tempe,  AZ  85282
Product CodeMOD  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-30
Decision Date2005-12-23
Summary:summary

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