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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K821910
Device Name ANESTHESIA & BRAIN MONITOR
Applicant
DATEX DIVISION INSTRUMENTARIUM CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DATEX DIVISION INSTRUMENTARIUM CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number890.1375
Classification Product Code
IKN  
Date Received06/28/1982
Decision Date 09/07/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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