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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K123470
Device Name PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
Applicant
Pas Systems International, Inc.
1616 Princess Anne St.
Fredericksburg,  VA  22401
Applicant Contact JAREL R KELSEY
Correspondent
Pas Systems International, Inc.
1616 Princess Anne St.
Fredericksburg,  VA  22401
Correspondent Contact JAREL R KELSEY
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received11/13/2012
Decision Date 04/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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