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FDA 510(k)

Solas OR

K-Number: K213691 · 2021-12-22

ApplicantCirdan Imaging, Ltd.
Decision Date2021-12-22
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Solas OR is the device name listed in this FDA 510(k) record. The listed applicant is Cirdan Imaging, Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213691. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solas OR?

Solas OR is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Cirdan Imaging, Ltd.. The 510(k) number is K213691.

When did Solas OR receive FDA 510(k) clearance?

Solas OR received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213691.

Who is the listed applicant for Solas OR?

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

What is the FDA product code for Solas OR?

The FDA product code for Solas OR is MWP.

Other records listing Cirdan Imaging, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MWP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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