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FDA 510(k) Application Details - K003175
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K003175
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
COMPUMEDICS LIMITED
6740 RIVERVIEW TERRACE
MINNEAPOLIS,, MN 55432 US
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Contact
CONSTANCE BUNDY
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLV
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More FDA Info for this Product Code
Date Received
10/10/2000
Decision Date
12/27/2000
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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