510(k) K945799
K945799 is an FDA 510(k) premarket notification submitted by The Magstim Company , Ltd. for the device "NEUROSIGN 100 IMPEDANCE METER". The FDA issued a decision of Substantially Equivalent on Jun 2, 1995. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. The Magstim Company , Ltd. has 22 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 1995
- Date Received
- Nov 28, 1994
- Clearance Type
- Traditional
- 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
- 510(k)