Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70

K-Number: K083801 · 2009-03-19

ApplicantKhn Solutions, LLC
Decision Date2009-03-19
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 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 2009-03-19 under 510(k) number K083801. 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, MODELS S30, S50, S70?

BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 is a medical device that received FDA 510(k) clearance on 2009-03-19. The listed applicant is Khn Solutions, LLC. The 510(k) number is K083801.

When did BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 receive FDA 510(k) clearance?

BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 received FDA 510(k) clearance on 2009-03-19, under 510(k) number K083801.

Who is the listed applicant for BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70?

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, MODELS S30, S50, S70?

The FDA product code for BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K090067BACTRACK SELECT BREATHALYZER, MODEL S80K071067BACTRACK 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.

↑