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FDA 510(k) Application Details - K001562
Device Classification Name
Electromyograph, Diagnostic
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510(K) Number
K001562
Device Name
Electromyograph, Diagnostic
Applicant
NEURO SCAN LABS
5700 CROMO DR., SUITE 100
EL PASO, TX 79912-5538 US
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Contact
DAVID B JONES
Other 510(k) Applications for this Contact
Regulation Number
890.1375
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Classification Product Code
IKN
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More FDA Info for this Product Code
Date Received
05/19/2000
Decision Date
08/16/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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