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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
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