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)

KEY RING ALCOHOL BREATHALYZER

K-Number: K082086 · 2008-12-19

ApplicantThe Ashley Collection, Inc.
Decision Date2008-12-19
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

KEY RING ALCOHOL BREATHALYZER is the device name listed in this FDA 510(k) record. The listed applicant is The Ashley Collection, Inc.. It received FDA 510(k) clearance on 2008-12-19 under 510(k) number K082086. 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 KEY RING ALCOHOL BREATHALYZER?

KEY RING ALCOHOL BREATHALYZER is a medical device that received FDA 510(k) clearance on 2008-12-19. The listed applicant is The Ashley Collection, Inc.. The 510(k) number is K082086.

When did KEY RING ALCOHOL BREATHALYZER receive FDA 510(k) clearance?

KEY RING ALCOHOL BREATHALYZER received FDA 510(k) clearance on 2008-12-19, under 510(k) number K082086.

Who is the listed applicant for KEY RING ALCOHOL BREATHALYZER?

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

What is the FDA product code for KEY RING ALCOHOL BREATHALYZER?

The FDA product code for KEY RING ALCOHOL BREATHALYZER 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

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.

↑