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510(k) K080848

ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR by Q3 Innovations, LLC — Product Code DJZ

K080848 is an FDA 510(k) premarket notification submitted by Q3 Innovations, LLC for the device "ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR". The FDA issued a decision of Substantially Equivalent on July 25, 2008. The device falls under product code DJZ (Devices, Breath Trapping, Alcohol), a Class I device regulated under 21 CFR 862.3050. Q3 Innovations, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2008
Date Received
March 26, 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 by Q3 Innovations, LLC

  • K043188 — ALCOHAWK PRECISION (February 9, 2005)

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)
  • K082080 — ALCO TUBE PLUS (April 1, 2009)

FDA data resources