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510(k) K123470

PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE by Pas Systems International, Inc. — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2013
Date Received
November 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices, Breath Trapping, Alcohol
Device Class
Class I
Regulation Number
862.3050
Review Panel
TX
Submission Type

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