NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
FDA 510(k) clearance K991583 · decided 1999-05-19
Clearance details
- K-number
- K991583
- Device name
- NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
- Applicant
- The Magstim Company , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-07
- Decision date
- 1999-05-19
- Days to decision
- 12 days
- Clearance type
- Special
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.