FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
K Number: K053141
·
Decision Dec 14, 2005
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
96
Applicant Total
13
Review Days
35
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Basic Information
- Device Name
- NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
- K Number
- K053141
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Magstim Company , Ltd.
- Date Received
- November 9, 2005
- Decision Date
- December 14, 2005
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by The Magstim Company , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro | Oct 25, 2023 | Substantially Equivalent |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | Aug 23, 2013 | Substantially Equivalent |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | Jul 29, 2009 | Substantially Equivalent |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | Dec 8, 2008 | Substantially Equivalent |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | Dec 12, 2007 | Substantially Equivalent |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 | Dec 21, 2005 | Substantially Equivalent |
| K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | May 19, 1999 | Substantially Equivalent |
| K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | Aug 5, 1998 | Substantially Equivalent |
| K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | May 14, 1997 | Substantially Equivalent |
| K945799 | NEUROSIGN 100 IMPEDANCE METER | Jun 2, 1995 | Substantially Equivalent |