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FDA 510(k)

EVS 2430W, EVS 2430GW

K-Number: K171137 · 2017-05-15

ApplicantDRTECH Corporation
Decision Date2017-05-15
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EVS 2430W, EVS 2430GW is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2017-05-15 under 510(k) number K171137. 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 EVS 2430W, EVS 2430GW?

EVS 2430W, EVS 2430GW is a medical device that received FDA 510(k) clearance on 2017-05-15. The listed applicant is DRTECH Corporation. The 510(k) number is K171137.

When did EVS 2430W, EVS 2430GW receive FDA 510(k) clearance?

EVS 2430W, EVS 2430GW received FDA 510(k) clearance on 2017-05-15, under 510(k) number K171137.

Who is the listed applicant for EVS 2430W, EVS 2430GW?

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

What is the FDA product code for EVS 2430W, EVS 2430GW?

The FDA product code for EVS 2430W, EVS 2430GW is MQB.

Other records listing DRTECH Corporation as applicant

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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

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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