MEB-2300A Neuropack Evoked Potential and Emg Measuring System
FDA 510(k) K120397 · Nihon Kohden Corp.
510(k) numberK120397
Submission
- Device name
- MEB-2300A Neuropack Evoked Potential and Emg Measuring System
- Applicant
- Nihon Kohden Corp.
Foothill, CA, US - Received
- February 8, 2012
- Decision date
- September 19, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MEB-2300A Neuropack Evoked Potential and Emg Measuring System cleared by the FDA?
MEB-2300A Neuropack Evoked Potential and Emg Measuring System (K120397) received a 510(k) decision of Substantially Equivalent on September 19, 2012, 224 days after the submission was received.
What is the product code of K120397?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.