510(k) K024316
K024316 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "NIM-PRS". The FDA issued a decision of Substantially Equivalent on January 6, 2003. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2003
- Date Received
- December 26, 2002
- 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