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FDA 510(k)

DRAEGER ALCOTEST 6510

K-Number: K063443 · 2008-03-11

ApplicantDrager Safety
Decision Date2008-03-11
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRAEGER ALCOTEST 6510 is the device name listed in this FDA 510(k) record. The listed applicant is Drager Safety. It received FDA 510(k) clearance on 2008-03-11 under 510(k) number K063443. 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 DRAEGER ALCOTEST 6510?

DRAEGER ALCOTEST 6510 is a medical device that received FDA 510(k) clearance on 2008-03-11. The listed applicant is Drager Safety. The 510(k) number is K063443.

When did DRAEGER ALCOTEST 6510 receive FDA 510(k) clearance?

DRAEGER ALCOTEST 6510 received FDA 510(k) clearance on 2008-03-11, under 510(k) number K063443.

Who is the listed applicant for DRAEGER ALCOTEST 6510?

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

What is the FDA product code for DRAEGER ALCOTEST 6510?

The FDA product code for DRAEGER ALCOTEST 6510 is DJZ.

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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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