SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM

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STUART MEDICAL, INC.

The following data is part of a premarket notification filed by Stuart Medical, Inc. with the FDA for Smi Model 210 Ambulatory Ecg Monitoring System.

Pre-market Notification Details

Device IDK920294
510k NumberK920294
Device Name:SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant STUART MEDICAL, INC. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
ContactLynne Aronson
CorrespondentLynne Aronson
STUART MEDICAL, INC. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
Product CodeLOS
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-22
Decision Date1992-07-07

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