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FDA 510(k)

REDLINE ALCOHOL BREATH TESTER

K-Number: K072953 · 2008-01-07

ApplicantRedline Products (Pty) , Ltd.
Decision Date2008-01-07
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

REDLINE ALCOHOL BREATH TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Redline Products (Pty) , Ltd.. It received FDA 510(k) clearance on 2008-01-07 under 510(k) number K072953. 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 REDLINE ALCOHOL BREATH TESTER?

REDLINE ALCOHOL BREATH TESTER is a medical device that received FDA 510(k) clearance on 2008-01-07. The listed applicant is Redline Products (Pty) , Ltd.. The 510(k) number is K072953.

When did REDLINE ALCOHOL BREATH TESTER receive FDA 510(k) clearance?

REDLINE ALCOHOL BREATH TESTER received FDA 510(k) clearance on 2008-01-07, under 510(k) number K072953.

Who is the listed applicant for REDLINE ALCOHOL BREATH TESTER?

The FDA 510(k) record lists Redline Products (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REDLINE ALCOHOL BREATH TESTER?

The FDA product code for REDLINE ALCOHOL BREATH TESTER is DJZ.

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Related Devices (Code: DJZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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