FDA 510(k) Application Details - K990522

Device Classification Name Standard Polysomnograph With Electroencephalograph

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510(K) Number K990522
Device Name Standard Polysomnograph With Electroencephalograph
Applicant LA MONT MEDICAL, INC.
555 D'ONOFRIO DR.
MADISON, WI 53719-2053 US
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Contact TONY MONTGOMERY
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Regulation Number 882.1400

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Classification Product Code OLV
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Date Received 02/18/1999
Decision Date 05/19/1999
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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