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FDA 510(k) Application Details - K972419
Device Classification Name
Electromyograph, Diagnostic
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510(K) Number
K972419
Device Name
Electromyograph, Diagnostic
Applicant
ERICH JAEGER, INC.
LEIBNIZSTRABE 7
D-97204
HOECHBERG, GERMANY DE
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Contact
D. GROTHEER
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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
06/27/1997
Decision Date
04/30/1998
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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