ARCHIMED 4210 AND 4220

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

BIOSOUND ESAOTE, INC.

The following data is part of a premarket notification filed by Biosound Esaote, Inc. with the FDA for Archimed 4210 And 4220.

Pre-market Notification Details

• Device ID: K973922
• 510k Number: K973922
• Device Name: ARCHIMED 4210 AND 4220
• 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: BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250
• Contact: Colleen Hittle
• Correspondent: Colleen Hittle; BIOSOUND ESAOTE, INC. 8000 CASTLEWAY DR. Indianapolis, IN 46250
• 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: 1997-10-15
• Decision Date: 1998-05-12
• Summary: summary