FDA 510(k) Application Details - K010897

Device Classification Name Device, Galvanic Skin Response Measurement

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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
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Regulation Number 882.1540

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Classification Product Code GZO
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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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