FDA 510(k) Application Details - K963669

Device Classification Name Amplifier, Physiological Signal

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510(K) Number K963669
Device Name Amplifier, Physiological Signal
Applicant ASTRO-MED, INC.
600 EAST GREENWICH AVE.
WEST WARWICK, RI 02893 US
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Contact STEVE JOHNSON
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Regulation Number 882.1835

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Classification Product Code GWL
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Date Received 09/13/1996
Decision Date 12/12/1996
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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