The following data is part of a premarket notification filed by Marquette Medical Systems, Inc. with the FDA for Acute Cardiac Ischemia Time-insensitive Predictive Instrument (aci-tipi) Option.
| Device ID | K974199 |
| 510k Number | K974199 |
| Device Name: | ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION |
| 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 | MARQUETTE MEDICAL SYSTEMS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Kristin Pabst |
| Correspondent | Kristin Pabst MARQUETTE MEDICAL SYSTEMS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| 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 | 1997-11-10 |
| Decision Date | 1998-02-06 |
| Summary: | summary |