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510(k) K082086

KEY RING ALCOHOL BREATHALYZER by The Ashley Collection, Inc. — Product Code DJZ

K082086 is an FDA 510(k) premarket notification submitted by The Ashley Collection, Inc. for the device "KEY RING ALCOHOL BREATHALYZER". The FDA issued a decision of Substantially Equivalent on December 19, 2008. 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
December 19, 2008
Date Received
July 23, 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

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

FDA data resources