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510(k) K080848

ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR by Q3 Innovations, LLC — Product Code DJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2008
Date Received
March 26, 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

Other clearances by Q3 Innovations, LLC

  • K043188 — ALCOHAWK PRECISION (February 9, 2005)

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