FDA 510(k)

Ziehm 8000

K-Number: K190497 · 2019-11-20

Decision Date2019-11-20

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ziehm 8000 is a medical device manufactured by Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2019-11-20 under approval number K190497. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ziehm 8000?

Ziehm 8000 is a medical device that received FDA 510(k) clearance on 2019-11-20. It is manufactured by Ziehm Imaging GmbH. The 510(k) number is K190497.

When was Ziehm 8000 approved by the FDA?

Ziehm 8000 received FDA 510(k) clearance on 2019-11-20, under approval number K190497.

What company makes Ziehm 8000?

Ziehm 8000 is manufactured by Ziehm Imaging GmbH.

What is the FDA product code for Ziehm 8000?

The FDA product code for Ziehm 8000 is OWB.

Other Devices by Ziehm Imaging GmbH

K161976Ziehm Solo FD K193230Ziehm Vision FD K202360Ziehm Vision RFD 3D K203428Ziehm Vision RFD K231700Ziehm Vision FD K231669Ziehm Solo FD

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Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

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.