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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K990522
Device Name WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
Applicant
Lamont Medical, Inc.
555 D'Onofrio Dr.
Madison,  WI  53719 -2053
Applicant Contact TONY MONTGOMERY
Correspondent
Lamont Medical, Inc.
555 D'Onofrio Dr.
Madison,  WI  53719 -2053
Correspondent Contact TONY MONTGOMERY
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received02/18/1999
Decision Date 05/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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