CARDIOVIT CS-200

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

The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Cardiovit Cs-200.

Device ID	K970879
510k Number	K970879
Device Name:	CARDIOVIT CS-200
Classification	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
Applicant	SCHILLER AMERICA, INC. 3002 DOW AVE., #138 Tustin, CA 92780
Contact	Markus Maritz
Correspondent	Markus Maritz SCHILLER AMERICA, INC. 3002 DOW AVE., #138 Tustin, CA 92780
Product Code	LOS
CFR Regulation Number	510(k) Premarket Notification [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	1997-03-10
Decision Date	1997-06-25