EKG-PLUS II SOFTWARE

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 CO., LTD.

The following data is part of a premarket notification filed by Bionet Co., Ltd. with the FDA for Ekg-plus Ii Software.

Pre-market Notification Details

• Device ID: K090895
• 510k Number: K090895
• Device Name: EKG-PLUS II SOFTWARE
• 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 CO., LTD. ROOM 431, LIFEOFFICETEL 61-3, YOIDO-DONG, YOUNGDEUNGPO -gu, Seoul, KR 150-731
• Contact: Hl Jung
• Correspondent: Hl Jung; BIONET CO., LTD. ROOM 431, LIFEOFFICETEL 61-3, YOIDO-DONG, YOUNGDEUNGPO -gu, Seoul, KR 150-731
• 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: 2009-03-30
• Decision Date: 2009-08-26
• Summary: summary