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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 K974587
Device Name H2O
Applicant
GRASS-TELEFACTOR PRODUCT GROUP
1094 NEW DEHAVEN AVE.
WEST CONSHOHOCKEN,  PA  19428
Applicant Contact JAMES S BRYAN
Correspondent
GRASS-TELEFACTOR PRODUCT GROUP
1094 NEW DEHAVEN AVE.
WEST CONSHOHOCKEN,  PA  19428
Correspondent Contact JAMES S BRYAN
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Codes
DQA   GWQ  
Date Received12/09/1997
Decision Date 03/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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