ECLIPSE 4 ELECTROCARDIOGRAPH

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

BURDICK, INC.

The following data is part of a premarket notification filed by Burdick, Inc. with the FDA for Eclipse 4 Electrocardiograph.

Pre-market Notification Details

• Device ID: K943959
• 510k Number: K943959
• Device Name: ECLIPSE 4 ELECTROCARDIOGRAPH
• 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: BURDICK, INC. 15 PLUMB ST. Milton, WI 53563 -1499
• Contact: Paul E Appel
• Correspondent: Paul E Appel; BURDICK, INC. 15 PLUMB ST. Milton, WI 53563 -1499
• 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: 1994-08-15
• Decision Date: 1995-05-17