510(k) K031995
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2004
- Date Received
- June 27, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromyograph, Diagnostic
- Device Class
- Class II
- Regulation Number
- 890.1375
- Review Panel
- NE
- Submission Type