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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 K862527
Device Name SLEEP ANALYZING COMPUTER
Applicant
MICROTRONICS CORP.
P.O. BOX 399
CARRBORO,  NC  27510
Applicant Contact KARLA SMITH
Correspondent
MICROTRONICS CORP.
P.O. BOX 399
CARRBORO,  NC  27510
Correspondent Contact KARLA SMITH
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Codes
OLT   OLV  
Date Received07/02/1986
Decision Date 10/06/1986
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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