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FDA 510(k) Application Details - K110223
Device Classification Name
Electrode, Cutaneous
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510(K) Number
K110223
Device Name
Electrode, Cutaneous
Applicant
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
8870 RAVELLO CT
NAPLES, FL 34114 US
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Contact
DANIEL KAMM
Other 510(k) Applications for this Contact
Regulation Number
882.1320
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Classification Product Code
GXY
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More FDA Info for this Product Code
Date Received
01/25/2011
Decision Date
06/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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