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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
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