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FDA 510(k)

LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER

K-Number: K090766 · 2009-07-23

Decision Date2009-07-23
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Lifeloc Technologies, Inc.. It received FDA 510(k) clearance on 2009-07-23 under 510(k) number K090766. 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 LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER?

LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER is a medical device that received FDA 510(k) clearance on 2009-07-23. The listed applicant is Lifeloc Technologies, Inc.. The 510(k) number is K090766.

When did LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER receive FDA 510(k) clearance?

LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER received FDA 510(k) clearance on 2009-07-23, under 510(k) number K090766.

Who is the listed applicant for LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER?

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

What is the FDA product code for LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER?

The FDA product code for LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER is DJZ.

Related Clinical Trials

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.

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.

Official Source

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

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