The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Cardiovit At-5c.
Device ID | K941462 |
510k Number | K941462 |
Device Name: | CARDIOVIT AT-5C |
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 | 1994-03-24 |
Decision Date | 1995-05-19 |