510(k) K060847
K060847 is an FDA 510(k) premarket notification submitted by Magstim Company Us, LLC for the device "MAGSTIM 200-2". The FDA issued a decision of Substantially Equivalent on Sep 26, 2006. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 2006
- Date Received
- Mar 28, 2006
- 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
- 510(k)