510(k) K053141
K053141 is an FDA 510(k) premarket notification submitted by The Magstim Company , Ltd. for the device "NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800". The FDA issued a decision of Substantially Equivalent on December 14, 2005. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. The Magstim Company , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2005
- Date Received
- November 9, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type