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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 polysomnograph with electroencephalograph
510(k) Number K871990
Device Name MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
Applicant
OXFORD MEDILOG, INC.
11526 53RD. ST. N.
CLEARWATER,  FL  33520
Applicant Contact MICHAEL J SMITH
Correspondent
OXFORD MEDILOG, INC.
11526 53RD. ST. N.
CLEARWATER,  FL  33520
Correspondent Contact MICHAEL J SMITH
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
OLV  
Date Received05/26/1987
Decision Date 10/07/1987
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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