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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 K001013
Device Name MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
Applicant
AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO,  NY  14228
Applicant Contact PETER WEISENBORN
Correspondent
AIRSEP CORP.
290 CREEKSIDE DR.
BUFFALO,  NY  14228
Correspondent Contact PETER WEISENBORN
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
DQA  
Date Received03/29/2000
Decision Date 05/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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