Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and Accessories
FDA 510(k) K990031 · Nihon Kohden America, Inc.
510(k) numberK990031
Submission
- Device name
- Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and Accessories
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- January 5, 1999
- Decision date
- April 16, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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| K993616 | Cardio-Card Interpretation System ILOS · Traditional | Nasiff Assoc., Inc. | 04/10/2000SE |
| 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 |
| K984504 | Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q and AccessoriesLOS · Traditional | Nihon Kohden America, Inc. | 04/15/1999SE |
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Questions and answers
When was Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and Accessories cleared by the FDA?
Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and Accessories (K990031) received a 510(k) decision of Substantially Equivalent on April 16, 1999, 101 days after the submission was received.