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510(k) K090067

BACTRACK SELECT BREATHALYZER, MODEL S80 by Khn Solutions, LLC — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2009
Date Received
January 9, 2009
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 Khn Solutions, LLC

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  • K071067 — BACTRACK LCD ALCOHOL DETECTOR (September 14, 2007)
  • K041334 — ALCOMATE, MODEL CA2000 (August 11, 2004)

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  • 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)