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FDA 510(k)

Cios Alpha

K-Number: K210055 · 2021-02-05

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-02-05
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cios Alpha is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K210055. 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 Cios Alpha?

Cios Alpha is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K210055.

When did Cios Alpha receive FDA 510(k) clearance?

Cios Alpha received FDA 510(k) clearance on 2021-02-05, under 510(k) number K210055.

Who is the listed applicant for Cios Alpha?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cios Alpha?

The FDA product code for Cios Alpha is OWB.

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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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