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FDA 510(k) Application Details - K100233
Device Classification Name
Device, Galvanic Skin Response Measurement
More FDA Info for this Device
510(K) Number
K100233
Device Name
Device, Galvanic Skin Response Measurement
Applicant
IMPETO MEDICAL
4479 SHOREPOINTS WAY
SAN DIEGO, CA 92130 US
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Contact
KYE CHEUNG
Other 510(k) Applications for this Contact
Regulation Number
882.1540
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Classification Product Code
GZO
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More FDA Info for this Product Code
Date Received
01/26/2010
Decision Date
06/14/2010
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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