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FDA 510(k) Application Details - K010897
Device Classification Name
Device, Galvanic Skin Response Measurement
More FDA Info for this Device
510(K) Number
K010897
Device Name
Device, Galvanic Skin Response Measurement
Applicant
MERIDIAN CO., LTD.
9FI SEOIL BLDG
222 JAMSILBON-DONG
SONGPA-GU, SEOUL KR
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Contact
SOO-RANG LEE
Other 510(k) Applications for this Contact
Regulation Number
882.1540
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Classification Product Code
GZO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/2001
Decision Date
06/19/2001
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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