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FDA 510(k)

ADX4000-L, DX3000-L

K-Number: K083532 · 2009-03-10

ApplicantDexcowin Co., Ltd.
Decision Date2009-03-10
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADX4000-L, DX3000-L is the device name listed in this FDA 510(k) record. The listed applicant is Dexcowin Co., Ltd.. It received FDA 510(k) clearance on 2009-03-10 under 510(k) number K083532. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADX4000-L, DX3000-L?

ADX4000-L, DX3000-L is a medical device that received FDA 510(k) clearance on 2009-03-10. The listed applicant is Dexcowin Co., Ltd.. The 510(k) number is K083532.

When did ADX4000-L, DX3000-L receive FDA 510(k) clearance?

ADX4000-L, DX3000-L received FDA 510(k) clearance on 2009-03-10, under 510(k) number K083532.

Who is the listed applicant for ADX4000-L, DX3000-L?

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

What is the FDA product code for ADX4000-L, DX3000-L?

The FDA product code for ADX4000-L, DX3000-L is MUH.

Other records listing Dexcowin 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.

K173046Cocoon Portable Handheld X-Ray System

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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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