510(k) K113074
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2012
- Date Received
- October 17, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electromyograph, Diagnostic
- Device Class
- Class II
- Regulation Number
- 890.1375
- Review Panel
- NE
- Submission Type