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510(k) K123470

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

K123470 is an FDA 510(k) premarket notification submitted by Pas Systems International, Inc. for the device "PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE". The FDA issued a decision of Substantially Equivalent on April 29, 2013. The device falls under product code DJZ (Devices, Breath Trapping, Alcohol), a Class I device regulated under 21 CFR 862.3050.

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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  • K110614 — PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM (November 21, 2011)
  • K102225 — ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST (April 6, 2011)
  • K102338 — BREATHSCN PRO (January 12, 2011)
  • K100879 — CONTRALCO (August 4, 2010)
  • K093143 — MISSION BREATH ALCOHOL DETECTOR (January 28, 2010)
  • K091714 — ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (November 18, 2009)
  • K090766 — LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER (July 23, 2009)
  • K082080 — ALCO TUBE PLUS (April 1, 2009)
  • K090067 — BACTRACK SELECT BREATHALYZER, MODEL S80 (March 24, 2009)

FDA data resources