CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
FDA 510(k) clearance K011328 · decided 2001-11-21
Clearance details
- K-number
- K011328
- Device name
- CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH
- Applicant
- Bionet Company, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-01
- Decision date
- 2001-11-21
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- LOS
- Advisory committee
- Unknown
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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| OXYCONALPHA WITH OPTION ECG (K984465) | Erich Jaeger B.V. | 1999-10-27 |
| CASE 8000 EXERCISE TESTING SYSTEM (K991014) | General Electric Medical Systems Information Techn | 1999-10-20 |
| MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS (K991735) | General Electric Medical Systems Information Techn | 1999-08-19 |
| NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (K990031) | Nihon Kohden America, Inc. | 1999-04-16 |
| NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (K984504) | Nihon Kohden America, Inc. | 1999-04-15 |
| MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K990266) | Micromedical Industries, Ltd. | 1999-02-02 |
| QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) (K981024) | Marquette Medical Systems, Inc. | 1998-10-06 |
Recalls involving this device
No recalls on record reference this clearance.