Home / 510(k) Clearances / K110614

510(k) K110614

PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM by Seju Engineering Co., Ltd. — Product Code DJZ

K110614 is an FDA 510(k) premarket notification submitted by Seju Engineering Co., Ltd. for the device "PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on November 21, 2011. 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
November 21, 2011
Date Received
March 3, 2011
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)
  • 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