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Neuropack
NIHON KOHDEN AMERICA, INC. · Model MEB-9400A-DT · UDI-DI 00841983103582
IKN
Prescription
10
510(k) clearances
111
Adverse events (2 deaths)
1
Recalls
69
Facilities
Description
MEB-9400 Neuropack S1 Laptop system; performs Evoked potentials, Nerve Conduction and Electromyography studies
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-01-29 | SpineMatrix Inc | A full design review of the CERSR system was conducted in 7/2009. The audit revealed numerous design verification tests that either did not pass or did not meet the design input r |
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