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FDA 510(k)

GR40CW

K-Number: K181631 · 2018-07-20

ApplicantSamsung Electronics Co., Ltd.
Decision Date2018-07-20
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GR40CW is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-07-20 under approval number K181631. 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 GR40CW?

GR40CW is a medical device that received FDA 510(k) clearance on 2018-07-20. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K181631.

When was GR40CW approved by the FDA?

GR40CW received FDA 510(k) clearance on 2018-07-20, under approval number K181631.

What company makes GR40CW?

GR40CW is manufactured by Samsung Electronics Co., Ltd..

What is the FDA product code for GR40CW?

The FDA product code for GR40CW is MQB.

Other Devices by Samsung Electronics Co., Ltd.

K163115GC70 K162278Digital Diagnostic Mobile X-ray System K160997GC85A K172229GC85A K171119GM85 K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A

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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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