510(k) K080499
K080499 is an FDA 510(k) premarket notification submitted by The Magstim Company , Ltd. for the device "MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00". The FDA issued a decision of Substantially Equivalent on December 8, 2008. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. The Magstim Company , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 2008
- Date Received
- February 25, 2008
- 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