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FDA 510(k) Application Details - K984052
Device Classification Name
Electromyograph, Diagnostic
More FDA Info for this Device
510(K) Number
K984052
Device Name
Electromyograph, Diagnostic
Applicant
OXFORD INSTRUMENTS MEDICAL SYSTEMS
P.O. BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact
E J SMITH
Other 510(k) Applications for this Contact
Regulation Number
890.1375
More FDA Info for this Regulation Number
Classification Product Code
IKN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/1998
Decision Date
05/17/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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