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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 K890513
Device Name SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
Applicant
MICROTRONICS CORP.
P.O. BOX 399
CARRBORO,  NC  27510
Applicant Contact JACK R SMITH
Correspondent
MICROTRONICS CORP.
P.O. BOX 399
CARRBORO,  NC  27510
Correspondent Contact JACK R SMITH
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
OLV  
Date Received02/01/1989
Decision Date 04/28/1989
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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