FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL 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

FUKUDA DENSHI USA, INC.

The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi: Cardiomax, Model Fx-4010 Multi Channel Electrocardiograph.

Pre-market Notification Details

• Device ID: K981066
• 510k Number: K981066
• Device Name: FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL 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: FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911
• Contact: David J Geraghty
• Correspondent: David J Geraghty; FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911
• 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: 1998-03-24
• Decision Date: 1998-08-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04538612901454	K981066	000
04538612904585	K981066	000
04538612028090	K981066	000