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FDA 510(k)

CRANEX D

K-Number: K043307 · 2004-12-17

ApplicantSoredex Palodex Group OY
Decision Date2004-12-17
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRANEX D is the device name listed in this FDA 510(k) record. The listed applicant is Soredex Palodex Group OY. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K043307. 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 CRANEX D?

CRANEX D is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Soredex Palodex Group OY. The 510(k) number is K043307.

When did CRANEX D receive FDA 510(k) clearance?

CRANEX D received FDA 510(k) clearance on 2004-12-17, under 510(k) number K043307.

Who is the listed applicant for CRANEX D?

The FDA 510(k) record lists Soredex Palodex Group OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANEX D?

The FDA product code for CRANEX D is EHD.

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Other records listing Soredex Palodex Group OY 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.

K110839SCANORA 3DK073350SCANORA 3DK070304DIGORA PCT/DIGIPODK063459CRANEX NOVUSK040382CRANEX BASEX D OR CRANEX EXCEL DK041050DIGORA OPTIME (OR DIGORA ONTIME)

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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

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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