CARDIOVIEW32 REVIEW MODULE

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

QRS DIAGNOSTIC, LLC.

The following data is part of a premarket notification filed by Qrs Diagnostic, Llc. with the FDA for Cardioview32 Review Module.

Pre-market Notification Details

• Device ID: K083749
• 510k Number: K083749
• Device Name: CARDIOVIEW32 REVIEW MODULE
• 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: QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH Plymouth, MN 55447
• Contact: Mary Kay Jensen
• Correspondent: Mary Kay Jensen; QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH Plymouth, MN 55447
• Product Code: LOS
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-17
• Decision Date: 2009-03-10
• Summary: summary