CARDIOTOUCH-3000
FDA 510(k) K023034 · Bionet Company, Ltd.
510(k) numberK023034
Submission
- Device name
- CARDIOTOUCH-3000
- Applicant
- Bionet Company, Ltd.
Alpharetta, GA, US - Received
- September 12, 2002
- Decision date
- November 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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| K011328 | Cardio Care EKG-2000 12-CHANNEL ElectrocardiographLOS · Traditional | Bionet Company, Ltd. | 11/21/2001SE |
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| K984465 | Oxyconalpha with Option ECGLOS · Traditional | Erich Jaeger B.V. | 10/27/1999SE |
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| K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac Vu, Mac 8…LOS · Traditional | General Electric Medical Systems Information Techn | 08/19/1999SE |
| K990031 | Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and AccessoriesLOS · Traditional | Nihon Kohden America, Inc. | 04/16/1999SE |
| K984504 | Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q and AccessoriesLOS · Traditional | Nihon Kohden America, Inc. | 04/15/1999SE |
More from Nihon Kohden America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231160 | Cardio Q50, Cardio Q70DPS · Traditional | 12/15/2023SE |
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| K220535 | Cardio10DPS · Traditional | 11/15/2022SE |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…IYN · Traditional | 10/11/2022SE |
| K130322 | SPM-300BZG · Traditional | 11/15/2013SE |
| K113306 | Cardio 7DPS · Traditional | 07/16/2012SE |
| K102767 | Cardio XPDPS · Traditional | 06/03/2011SE |
| K090895 | Ekg-Plus II SoftwareLOS · Traditional | 08/26/2009SE |
| K082008 | Bionet BM3PLUS Patient MonitorMWI · Traditional | 12/11/2008SE |
| K043598 | FC 1400 Fetal MonitorHGM · Traditional | 12/16/2005SE |
Questions and answers
When was CARDIOTOUCH-3000 cleared by the FDA?
CARDIOTOUCH-3000 (K023034) received a 510(k) decision of Substantially Equivalent on November 14, 2002, 63 days after the submission was received.