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FDA 510(k)

OnyxCeph

K-Number: K213263 · 2023-01-04

ApplicantImage Instruments GmbH
Decision Date2023-01-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OnyxCeph is a medical device manufactured by Image Instruments GmbH. It received FDA 510(k) clearance on 2023-01-04 under approval number K213263. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OnyxCeph?

OnyxCeph is a medical device that received FDA 510(k) clearance on 2023-01-04. It is manufactured by Image Instruments GmbH. The 510(k) number is K213263.

When was OnyxCeph approved by the FDA?

OnyxCeph received FDA 510(k) clearance on 2023-01-04, under approval number K213263.

What company makes OnyxCeph?

OnyxCeph is manufactured by Image Instruments GmbH.

What is the FDA product code for OnyxCeph?

The FDA product code for OnyxCeph is LLZ.

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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.

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