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FDA 510(k)

Ziehm 8000

K-Number: K190497 · 2019-11-20

ApplicantZiehm Imaging GmbH
Decision Date2019-11-20
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ziehm 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2019-11-20 under 510(k) 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. The listed applicant is Ziehm Imaging GmbH. The 510(k) number is K190497.

When did Ziehm 8000 receive FDA 510(k) clearance?

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

Who is the listed applicant for Ziehm 8000?

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

What is the FDA product code for Ziehm 8000?

The FDA product code for Ziehm 8000 is OWB.

Other records listing Ziehm Imaging GmbH as applicant

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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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