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FDA 510(k)

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)

K-Number: K081855 · 2008-12-19

ApplicantCanada, Inc.
Decision Date2008-12-19
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) is the device name listed in this FDA 510(k) record. The listed applicant is Canada, Inc.. It received FDA 510(k) clearance on 2008-12-19 under 510(k) number K081855. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)?

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) is a medical device that received FDA 510(k) clearance on 2008-12-19. The listed applicant is Canada, Inc.. The 510(k) number is K081855.

When did IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) receive FDA 510(k) clearance?

IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) received FDA 510(k) clearance on 2008-12-19, under 510(k) number K081855.

Who is the listed applicant for IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)?

The FDA 510(k) record lists Canada, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)?

The FDA product code for IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) is DJZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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