CORNEOMAP 4500 ULTRASOUND MEASUREMENT

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RADIONICS MEDICAL, INC.

The following data is part of a premarket notification filed by Radionics Medical, Inc. with the FDA for Corneomap 4500 Ultrasound Measurement.

Pre-market Notification Details

Device IDK837331
510k NumberK837331
Device Name:CORNEOMAP 4500 ULTRASOUND MEASUREMENT
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 RADIONICS MEDICAL, INC. 1240 ELLESMERE ROAD Scarborough, Ontario, Can,  CA
Product Code510(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 &
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-10
Decision Date1983-05-09

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