510(k) K011328
- Device
- CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
- Applicant
- BIONET COMPANY LTD
- 510(k) number
- K011328
- Product code
- LOS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-21
- Date received
- 2001-05-01
- Regulation
- 510(k) Premarket Notification
- Classification name
- 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
- Medical specialty
- 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
- Review panel
- Cardiovascular
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MIN SOO HAN
- Address
- 3f, Daeyang Bldg., 999 Daechi-Dong, Kangnam-Gu Seoul KR
FDA Registration Numbers#
- 3010381606
- 1319390
- 3031158
- 8030978
- 3003857828
- 3003681187
- 2433214
- 3009443693
- 1126271
- 3007184699
- 3010082909
Source Documents#
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases