12SSL ECG ANALYSIS PROG.(SCALER LEAD)

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MARQUETTE ELECTRONICS, INC.

The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for 12ssl Ecg Analysis Prog.(scaler Lead).

Pre-market Notification Details

Device IDK802369
510k NumberK802369
Device Name:12SSL ECG ANALYSIS PROG.(SCALER LEAD)
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 MARQUETTE ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLOS
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-09-29
Decision Date1980-11-12

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