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510(k) K063443

DRAEGER ALCOTEST 6510 by Drager Safety — Product Code DJZ

K063443 is an FDA 510(k) premarket notification submitted by Drager Safety for the device "DRAEGER ALCOTEST 6510". The FDA issued a decision of Substantially Equivalent on March 11, 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
March 11, 2008
Date Received
November 14, 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

Other clearances for product code DJZ

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  • 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