CARDIO CARE EKG-2000 12-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

BIONET COMPANY LTD

The following data is part of a premarket notification filed by Bionet Company Ltd with the FDA for Cardio Care Ekg-2000 12-channel Electrocardiograph.

Pre-market Notification Details

• Device ID: K011328
• 510k Number: K011328
• Device Name: CARDIO CARE EKG-2000 12-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: BIONET COMPANY LTD 3F, DAEYANG BLDG., 999 DAECHI-DONG, KANGNAM-GU Seoul, KR
• Contact: Min Soo Han
• Correspondent: Min Soo Han; BIONET COMPANY LTD 3F, DAEYANG BLDG., 999 DAECHI-DONG, KANGNAM-GU Seoul, KR
• 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: 2001-05-01
• Decision Date: 2001-11-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18809276943535	K011328	000