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510(k) K082080

ALCO TUBE PLUS by Alcotest Quebec — Product Code DJZ

K082080 is an FDA 510(k) premarket notification submitted by Alcotest Quebec for the device "ALCO TUBE PLUS". The FDA issued a decision of Substantially Equivalent on April 1, 2009. 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 1, 2009
Date Received
July 23, 2008
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

Other clearances for product code DJZ

  • K160613 — Soberlink Cellular Device and Sober Sky Web Portal (July 14, 2016)
  • K123470 — PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE (April 29, 2013)
  • 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)
  • K090067 — BACTRACK SELECT BREATHALYZER, MODEL S80 (March 24, 2009)

FDA data resources