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FDA 510(k)

RX DC X-RAY UNIT

K-Number: K080076 · 2008-03-14

ApplicantCefla S.C.R.L.
Decision Date2008-03-14
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RX DC X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.R.L.. It received FDA 510(k) clearance on 2008-03-14 under 510(k) number K080076. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX DC X-RAY UNIT?

RX DC X-RAY UNIT is a medical device that received FDA 510(k) clearance on 2008-03-14. The listed applicant is Cefla S.C.R.L.. The 510(k) number is K080076.

When did RX DC X-RAY UNIT receive FDA 510(k) clearance?

RX DC X-RAY UNIT received FDA 510(k) clearance on 2008-03-14, under 510(k) number K080076.

Who is the listed applicant for RX DC X-RAY UNIT?

The FDA 510(k) record lists Cefla S.C.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RX DC X-RAY UNIT?

The FDA product code for RX DC X-RAY UNIT is EHD.

Other records listing Cefla S.C.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062897C-U2K061114WDS, SIZE 2 AND SIZE 2

Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

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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