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510(k) K062545

RMI LCD ALCOHOL DETECTOR by Resource Management International, LLC — Product Code DJZ

K062545 is an FDA 510(k) premarket notification submitted by Resource Management International, LLC for the device "RMI LCD ALCOHOL DETECTOR". The FDA issued a decision of Substantially Equivalent on April 9, 2007. 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 9, 2007
Date Received
August 30, 2006
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)

FDA data resources