SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM

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

STUART MEDICAL, INC.

The following data is part of a premarket notification filed by Stuart Medical, Inc. with the FDA for Smi Model 210 Ambulatory Ecg Monitoring System.

Pre-market Notification Details

• Device ID: K920294
• 510k Number: K920294
• Device Name: SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM
• 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: STUART MEDICAL, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703
• Contact: Lynne Aronson
• Correspondent: Lynne Aronson; STUART MEDICAL, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703
• 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: 1992-01-22
• Decision Date: 1992-07-07