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FDA 510(k) Application Details - K050143
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K050143
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
MAYS AND ASSOCIATES, INC.
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071-3404 US
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Contact
HARVEY KNAUSS
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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
01/21/2005
Decision Date
02/01/2005
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
Y
Expedited Review
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