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FDA 510(k)

ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR

K-Number: K080848 · 2008-07-25

ApplicantQ3 Innovations, LLC
Decision Date2008-07-25
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Q3 Innovations, LLC. It received FDA 510(k) clearance on 2008-07-25 under 510(k) number K080848. 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 ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR?

ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR is a medical device that received FDA 510(k) clearance on 2008-07-25. The listed applicant is Q3 Innovations, LLC. The 510(k) number is K080848.

When did ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR receive FDA 510(k) clearance?

ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR received FDA 510(k) clearance on 2008-07-25, under 510(k) number K080848.

Who is the listed applicant for ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR?

The FDA 510(k) record lists Q3 Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR?

The FDA product code for ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR 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 Q3 Innovations, 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.

K043188ALCOHAWK PRECISION

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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