510(k) K992911
K992911 is an FDA 510(k) premarket notification submitted by Magstim Corporation US for the device "MAGSTIM RAPID". The FDA issued a decision of Substantially Equivalent on Jan 7, 2000. 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
- Jan 7, 2000
- Date Received
- Aug 30, 1999
- 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)