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FDA 510(k)

BEMITT, MODEL 0001

K-Number: K071787 · 2007-10-26

ApplicantDja Distributors, LLC
Decision Date2007-10-26
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BEMITT, MODEL 0001 is the device name listed in this FDA 510(k) record. The listed applicant is Dja Distributors, LLC. It received FDA 510(k) clearance on 2007-10-26 under 510(k) number K071787. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEMITT, MODEL 0001?

BEMITT, MODEL 0001 is a medical device that received FDA 510(k) clearance on 2007-10-26. The listed applicant is Dja Distributors, LLC. The 510(k) number is K071787.

When did BEMITT, MODEL 0001 receive FDA 510(k) clearance?

BEMITT, MODEL 0001 received FDA 510(k) clearance on 2007-10-26, under 510(k) number K071787.

Who is the listed applicant for BEMITT, MODEL 0001?

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

What is the FDA product code for BEMITT, MODEL 0001?

The FDA product code for BEMITT, MODEL 0001 is IZH.

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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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