510(k) K191975
K191975 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Elefix V Paste for EEG & EMG". The FDA issued a decision of Substantially Equivalent on February 7, 2020. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2020
- Date Received
- July 24, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Electroconductive
- Device Class
- Class II
- Regulation Number
- 882.1275
- Review Panel
- NE
- Submission Type