FDA 510(k)

A1417MCW/A1717MCW/F1417MCW

K-Number: K223930 · 2023-03-06

Decision Date2023-03-06

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

A1417MCW/A1717MCW/F1417MCW is a medical device manufactured by H&abyz Co., Ltd.. It received FDA 510(k) clearance on 2023-03-06 under approval number K223930. 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 A1417MCW/A1717MCW/F1417MCW?

A1417MCW/A1717MCW/F1417MCW is a medical device that received FDA 510(k) clearance on 2023-03-06. It is manufactured by H&abyz Co., Ltd.. The 510(k) number is K223930.

When was A1417MCW/A1717MCW/F1417MCW approved by the FDA?

A1417MCW/A1717MCW/F1417MCW received FDA 510(k) clearance on 2023-03-06, under approval number K223930.

What company makes A1417MCW/A1717MCW/F1417MCW?

A1417MCW/A1717MCW/F1417MCW is manufactured by H&abyz Co., Ltd..

What is the FDA product code for A1417MCW/A1717MCW/F1417MCW?

The FDA product code for A1417MCW/A1717MCW/F1417MCW is MQB.

Other Devices by H&abyz Co., Ltd.

K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) K203188ADD K251223HnX-P1, HnX-PB

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.