CARDIOSMART ST

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

MARQUETTE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Marquette Medical Systems, Inc. with the FDA for Cardiosmart St.

Pre-market Notification Details

• Device ID: K973403
• 510k Number: K973403
• Device Name: CARDIOSMART ST
• 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: Dianne Schmitz
• Correspondent: Dianne Schmitz; 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: 1997-09-09
• Decision Date: 1998-03-12
• Summary: summary