510(k) K142624
K142624 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "Neuromaster G1 MEE200". The FDA issued a decision of Substantially Equivalent on April 24, 2015. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2015
- Date Received
- September 16, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type