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FDA 510(k) Application Details - K010460
Device Classification Name
Standard Polysomnograph With Electroencephalograph
More FDA Info for this Device
510(K) Number
K010460
Device Name
Standard Polysomnograph With Electroencephalograph
Applicant
LIFELINES LTD.
PO BOX 4341
CROFTON, MD 21114 US
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Contact
CRHISTINA SMITH
Other 510(k) Applications for this Contact
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
02/16/2001
Decision Date
05/14/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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