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FDA 510(k)

SDX-4343CS

K-Number: K112751 · 2011-11-23

ApplicantSamsung Mobile Display Co., Ltd.
Decision Date2011-11-23
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SDX-4343CS is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Mobile Display Co., Ltd.. It received FDA 510(k) clearance on 2011-11-23 under 510(k) number K112751. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDX-4343CS?

SDX-4343CS is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Samsung Mobile Display Co., Ltd.. The 510(k) number is K112751.

When did SDX-4343CS receive FDA 510(k) clearance?

SDX-4343CS received FDA 510(k) clearance on 2011-11-23, under 510(k) number K112751.

Who is the listed applicant for SDX-4343CS?

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

What is the FDA product code for SDX-4343CS?

The FDA product code for SDX-4343CS is MQB.

Other records listing Samsung Mobile Display Co., Ltd. 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.

K112558DIGITAL FLAT PANEL X-RAY DETECTORK102321DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CPK102587LLX240AB01K090742DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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