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FDA 510(k)

HAWK INTRAORAL CAMERA AND ACCESSORIES

K-Number: K040116 · 2004-04-20

ApplicantDxm Co., Ltd.
Decision Date2004-04-20
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HAWK INTRAORAL CAMERA AND ACCESSORIES 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 2004-04-20 under 510(k) number K040116. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAWK INTRAORAL CAMERA AND ACCESSORIES?

HAWK INTRAORAL CAMERA AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2004-04-20. The listed applicant is Dxm Co., Ltd.. The 510(k) number is K040116.

When did HAWK INTRAORAL CAMERA AND ACCESSORIES receive FDA 510(k) clearance?

HAWK INTRAORAL CAMERA AND ACCESSORIES received FDA 510(k) clearance on 2004-04-20, under 510(k) number K040116.

Who is the listed applicant for HAWK INTRAORAL CAMERA AND ACCESSORIES?

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 HAWK INTRAORAL CAMERA AND ACCESSORIES?

The FDA product code for HAWK INTRAORAL CAMERA AND ACCESSORIES is EIA.

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Related Devices (Code: EIA)

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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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