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FDA 510(k)

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP

K-Number: K193017 · 2019-11-22

ApplicantDRTECH Corporation
Decision Date2019-11-22
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP is a medical device manufactured by DRTECH Corporation. It received FDA 510(k) clearance on 2019-11-22 under approval number K193017. 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 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP?

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by DRTECH Corporation. The 510(k) number is K193017.

When was EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP approved by the FDA?

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP received FDA 510(k) clearance on 2019-11-22, under approval number K193017.

What company makes EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP?

EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP is manufactured by DRTECH Corporation.

What is the FDA product code for EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP?

The FDA product code for EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP is MQB.

Other Devices by DRTECH Corporation

K162555EVS 4343, EVS 4343G K162552EVS 3643, EVS 3643G K171137EVS 2430W, EVS 2430GW K170930RSM 2430C K162670RSM 1824C with RConsole1 K193031EXPD 4343P, EXPD 3643P

View all 22 devices →

Related Devices (Code: MQB)

K162555EVS 4343, EVS 4343GDRTECH Corporation K162344INNOLUX RICInnolux Corporation K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai) , Ltd. K162552EVS 3643, EVS 3643GDRTECH Corporation K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd. K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, 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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