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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, peripheral, electric
510(k) Number K840108
Device Name NEUROMUSCULAR TRANSMISSION 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 Number868.2775
Classification Product Code
KOI  
Date Received01/10/1984
Decision Date 02/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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