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510(k) K920627

Device
MODEL ELI 100 ELECTROCARDIOGRAPH
Applicant
MORTARA INSTRUMENT, INC.
510(k) number
K920627
Product code
LOS
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-04
Date received
1992-01-29
Regulation
510(k) Premarket Notification
Classification name
510(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
Medical specialty
510(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
Review panel
Cardiovascular
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN PRIMOZICH
Address
7865 N. 86th St. Milwaukee WI US 53224 53224

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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