The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Cardiovit Cs-100.
Device ID | K914970 |
510k Number | K914970 |
Device Name: | CARDIOVIT CS-100 |
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 AVENUE #122 Tustin, CA 92680 |
Contact | Markus Maritz |
Correspondent | Markus Maritz SCHILLER AMERICA, INC. 3002 DOW AVENUE #122 Tustin, CA 92680 |
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 | 1991-11-05 |
Decision Date | 1992-11-03 |