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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Full-Montage Electroencephalograph
510(k) Number K944833
Device Name DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
Applicant
New England Medical Monitoring Co.
286 Congress St.
Boston,  MA  02210
Applicant Contact PETER B LEONE
Correspondent
New England Medical Monitoring Co.
286 Congress St.
Boston,  MA  02210
Correspondent Contact PETER B LEONE
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
GWQ   OLV  
Date Received09/30/1994
Decision Date 05/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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