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FDA 510(k)

PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM

K-Number: K110614 · 2011-11-21

ApplicantSeju Engineering Co., Ltd.
Decision Date2011-11-21
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seju Engineering Co., Ltd.. It received FDA 510(k) clearance on 2011-11-21 under 510(k) number K110614. 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 PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM?

PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-21. The listed applicant is Seju Engineering Co., Ltd.. The 510(k) number is K110614.

When did PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM receive FDA 510(k) clearance?

PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM received FDA 510(k) clearance on 2011-11-21, under 510(k) number K110614.

Who is the listed applicant for PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM?

The FDA 510(k) record lists Seju Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM?

The FDA product code for PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM is DJZ.

Related Clinical Trials

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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.K102225ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TESTAlcopro, Inc.K102338BREATHSCN PROAkers Biosciences, Inc.K100879CONTRALCOContralcoK093143MISSION BREATH ALCOHOL DETECTORACON Laboratories, Inc.

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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