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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 K961638
Device Name MEDILOG MPA-S
Applicant
OXFORD INSTRUMENTS MEDICAL SYSTEMS
11526 53ND ST. N
CLEARWATER,  FL  34620
Applicant Contact CHARLES HOLZ
Correspondent
OXFORD INSTRUMENTS MEDICAL SYSTEMS
11526 53ND ST. N
CLEARWATER,  FL  34620
Correspondent Contact CHARLES HOLZ
Regulation Number882.1400
Classification Product Code
OLV  
Date Received04/29/1996
Decision Date 01/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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