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FDA 510(k)

DENJECTOR

K-Number: K081694 · 2008-09-12

ApplicantDxm Co., Ltd.
Decision Date2008-09-12
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Dxm Co., Ltd.. It received FDA 510(k) clearance on 2008-09-12 under 510(k) number K081694. The device is classified under product code EJI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENJECTOR?

DENJECTOR is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Dxm Co., Ltd.. The 510(k) number is K081694.

When did DENJECTOR receive FDA 510(k) clearance?

DENJECTOR received FDA 510(k) clearance on 2008-09-12, under 510(k) number K081694.

Who is the listed applicant for DENJECTOR?

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

What is the FDA product code for DENJECTOR?

The FDA product code for DENJECTOR is EJI.

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Related Devices (Code: EJI)

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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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