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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, Battery-Powered
510(k) Number K853476
Device Name T4 MONITOR STIMULATOR COMPUTER
Applicant
Regional Master Corp.
P.O. Box 431832
Miami,  FL  33143
Applicant Contact MARGARITA PLAZA
Correspondent
Regional Master Corp.
P.O. Box 431832
Miami,  FL  33143
Correspondent Contact MARGARITA PLAZA
Regulation Number868.2775
Classification Product Code
BXN  
Date Received08/14/1985
Decision Date 01/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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