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FDA 510(k)

BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000

K-Number: K060343 · 2006-05-11

ApplicantSentech Korea Corp.
Decision Date2006-05-11
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 is the device name listed in this FDA 510(k) record. The listed applicant is Sentech Korea Corp.. It received FDA 510(k) clearance on 2006-05-11 under 510(k) number K060343. 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 BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000?

BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 is a medical device that received FDA 510(k) clearance on 2006-05-11. The listed applicant is Sentech Korea Corp.. The 510(k) number is K060343.

When did BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 receive FDA 510(k) clearance?

BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 received FDA 510(k) clearance on 2006-05-11, under 510(k) number K060343.

Who is the listed applicant for BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000?

The FDA 510(k) record lists Sentech Korea Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000?

The FDA product code for BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000 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.

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Other records listing Sentech Korea Corp. 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.

K061922BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000K053332BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500

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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