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FDA 510(k)

DRAGON LW

K-Number: K121410 · 2012-08-02

ApplicantSedecal., Sa.
Decision Date2012-08-02
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRAGON LW is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2012-08-02 under 510(k) number K121410. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAGON LW?

DRAGON LW is a medical device that received FDA 510(k) clearance on 2012-08-02. The listed applicant is Sedecal., Sa.. The 510(k) number is K121410.

When did DRAGON LW receive FDA 510(k) clearance?

DRAGON LW received FDA 510(k) clearance on 2012-08-02, under 510(k) number K121410.

Who is the listed applicant for DRAGON LW?

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

What is the FDA product code for DRAGON LW?

The FDA product code for DRAGON LW is IZL.

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Other records listing Sedecal., Sa. as applicant

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Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom 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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