IntelliCart System

Apparatus, Suction, Ward Use, Portable, Ac-powered

Dornoch Medical Systems

The following data is part of a premarket notification filed by Dornoch Medical Systems with the FDA for Intellicart System.

Pre-market Notification Details

Device IDK172481
510k NumberK172481
Device Name:IntelliCart System
ClassificationApparatus, Suction, Ward Use, Portable, Ac-powered
Applicant Dornoch Medical Systems 200 North West Parkway Riverside,  MO  64150
ContactLarry Smith
CorrespondentMichael Wolford
Dornoch Medical Systems 200 West Parkway Riverside,  MO  64150
Product CodeJCX  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-16
Decision Date2017-09-14
Summary:summary

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