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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 K914164
Device Name VITALMAX 840 SERIES
Applicant
Pace Tech Medical Monitors, Inc.
510 Garden Ave.North
Clearwater,  FL  34615
Correspondent
Pace Tech Medical Monitors, Inc.
510 Garden Ave.North
Clearwater,  FL  34615
Regulation Number868.2775
Classification Product Code
BXN  
Date Received09/17/1991
Decision Date 04/09/1993
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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