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FDA 510(k)

BACTRACK SELECT BREATHALYZER, MODEL S80

K-Number: K090067 · 2009-03-24

ApplicantKhn Solutions, LLC
Decision Date2009-03-24
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BACTRACK SELECT BREATHALYZER, MODEL S80 is the device name listed in this FDA 510(k) record. The listed applicant is Khn Solutions, LLC. It received FDA 510(k) clearance on 2009-03-24 under 510(k) number K090067. 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 BACTRACK SELECT BREATHALYZER, MODEL S80?

BACTRACK SELECT BREATHALYZER, MODEL S80 is a medical device that received FDA 510(k) clearance on 2009-03-24. The listed applicant is Khn Solutions, LLC. The 510(k) number is K090067.

When did BACTRACK SELECT BREATHALYZER, MODEL S80 receive FDA 510(k) clearance?

BACTRACK SELECT BREATHALYZER, MODEL S80 received FDA 510(k) clearance on 2009-03-24, under 510(k) number K090067.

Who is the listed applicant for BACTRACK SELECT BREATHALYZER, MODEL S80?

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

What is the FDA product code for BACTRACK SELECT BREATHALYZER, MODEL S80?

The FDA product code for BACTRACK SELECT BREATHALYZER, MODEL S80 is DJZ.

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Other records listing Khn Solutions, LLC as applicant

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.

K083801BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70K071067BACTRACK LCD ALCOHOL DETECTORK041334ALCOMATE, MODEL CA2000

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.

K160613Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLCK123470PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITEPas Systems International, Inc.K110614PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEMSeju Engineering Co., Ltd.K102225ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TESTAlcopro, Inc.K102338BREATHSCN PROAkers Biosciences, Inc.K100879CONTRALCOContralco

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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