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510(k) K091714

ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 by Skyfine Inc. Limited — Product Code DJZ

K091714 is an FDA 510(k) premarket notification submitted by Skyfine Inc. Limited for the device "ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579". The FDA issued a decision of Substantially Equivalent on November 18, 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
November 18, 2009
Date Received
June 10, 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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FDA data resources