Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q and Accessories
FDA 510(k) K984504 · Nihon Kohden America, Inc.
510(k) numberK984504
Submission
- Device name
- Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q and Accessories
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- December 18, 1998
- Decision date
- April 15, 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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Questions and answers
When was Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q and Accessories cleared by the FDA?
Nihon Kohden ECG-9110K and ECG-9130K Cardiofax Q and Accessories (K984504) received a 510(k) decision of Substantially Equivalent on April 15, 1999, 118 days after the submission was received.