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510(k) K090766

LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER by Lifeloc Technologies, Inc. — Product Code DJZ

K090766 is an FDA 510(k) premarket notification submitted by Lifeloc Technologies, Inc. for the device "LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER". The FDA issued a decision of Substantially Equivalent on July 23, 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
July 23, 2009
Date Received
March 23, 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

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  • K102338 — BREATHSCN PRO (January 12, 2011)
  • K100879 — CONTRALCO (August 4, 2010)
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  • K091714 — ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 (November 18, 2009)
  • K082080 — ALCO TUBE PLUS (April 1, 2009)
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FDA data resources