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FDA 510(k)

RMI LCD ALCOHOL DETECTOR

K-Number: K062545 · 2007-04-09

ApplicantResource Management International, LLC
Decision Date2007-04-09
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RMI LCD ALCOHOL DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Resource Management International, LLC. It received FDA 510(k) clearance on 2007-04-09 under 510(k) number K062545. 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 RMI LCD ALCOHOL DETECTOR?

RMI LCD ALCOHOL DETECTOR is a medical device that received FDA 510(k) clearance on 2007-04-09. The listed applicant is Resource Management International, LLC. The 510(k) number is K062545.

When did RMI LCD ALCOHOL DETECTOR receive FDA 510(k) clearance?

RMI LCD ALCOHOL DETECTOR received FDA 510(k) clearance on 2007-04-09, under 510(k) number K062545.

Who is the listed applicant for RMI LCD ALCOHOL DETECTOR?

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

What is the FDA product code for RMI LCD ALCOHOL DETECTOR?

The FDA product code for RMI LCD ALCOHOL DETECTOR is DJZ.

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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.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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