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)

ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579

K-Number: K091714 · 2009-11-18

ApplicantSkyfine Inc. Limited
Decision Date2009-11-18
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 is the device name listed in this FDA 510(k) record. The listed applicant is Skyfine Inc. Limited. It received FDA 510(k) clearance on 2009-11-18 under 510(k) number K091714. 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 ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579?

ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 is a medical device that received FDA 510(k) clearance on 2009-11-18. The listed applicant is Skyfine Inc. Limited. The 510(k) number is K091714.

When did ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 receive FDA 510(k) clearance?

ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 received FDA 510(k) clearance on 2009-11-18, under 510(k) number K091714.

Who is the listed applicant for ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579?

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

What is the FDA product code for ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579?

The FDA product code for ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 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.

↑