CARDIOVIT CS-100

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

SCHILLER AMERICA, INC.

The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Cardiovit Cs-100.

Pre-market Notification Details

Device IDK914970
510k NumberK914970
Device Name:CARDIOVIT CS-100
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 SCHILLER AMERICA, INC. 3002 DOW AVENUE #122 Tustin,  CA  92680
ContactMarkus Maritz
CorrespondentMarkus Maritz
SCHILLER AMERICA, INC. 3002 DOW AVENUE #122 Tustin,  CA  92680
Product CodeLOS
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-05
Decision Date1992-11-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.