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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 -4126
Correspondent
PACE TECH MEDICAL MONITORS, INC.
510 GARDEN AVE.NORTH
CLEARWATER,  FL  34615 -4126
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
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