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FDA 510(k) Application Details - K970951
Device Classification Name
Standard Polysomnograph With Electroencephalograph
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510(K) Number
K970951
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
ASTRO-MED, INC.
600 EAST GREENWICH AVE.
WEST WARWICK, RI 02893 US
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Contact
STEPHEN E JOHNSON
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Regulation Number
882.1400
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Classification Product Code
OLV
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More FDA Info for this Product Code
Date Received
03/14/1997
Decision Date
05/19/1997
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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