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FDA 510(k)

POCKET BREATHALYZER. CONNECTABLES

K-Number: K052448 · 2006-02-23

ApplicantConnectables, LLC
Decision Date2006-02-23
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

POCKET BREATHALYZER. CONNECTABLES is the device name listed in this FDA 510(k) record. The listed applicant is Connectables, LLC. It received FDA 510(k) clearance on 2006-02-23 under 510(k) number K052448. 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 POCKET BREATHALYZER. CONNECTABLES?

POCKET BREATHALYZER. CONNECTABLES is a medical device that received FDA 510(k) clearance on 2006-02-23. The listed applicant is Connectables, LLC. The 510(k) number is K052448.

When did POCKET BREATHALYZER. CONNECTABLES receive FDA 510(k) clearance?

POCKET BREATHALYZER. CONNECTABLES received FDA 510(k) clearance on 2006-02-23, under 510(k) number K052448.

Who is the listed applicant for POCKET BREATHALYZER. CONNECTABLES?

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

What is the FDA product code for POCKET BREATHALYZER. CONNECTABLES?

The FDA product code for POCKET BREATHALYZER. CONNECTABLES is DJZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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