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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 K934599
Device Name SANDMAN
Applicant
MELVILLE SOFTWARE LTD.
350 SPARKS ST.
SUITE 1007
OTTAWA, ONTARIO,  CA K1R 7S8
Applicant Contact DAVID N BAKER
Correspondent
MELVILLE SOFTWARE LTD.
350 SPARKS ST.
SUITE 1007
OTTAWA, ONTARIO,  CA K1R 7S8
Correspondent Contact DAVID N BAKER
Regulation Number882.1400
Classification Product Code
OLV  
Date Received09/24/1993
Decision Date 01/27/1994
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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