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FDA 510(k)

Aggeris™-C

K-Number: K220182 · 2022-03-30

ApplicantClariance
Decision Date2022-03-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aggeris™-C is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K220182. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aggeris™-C?

Aggeris™-C is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is Clariance. The 510(k) number is K220182.

When did Aggeris™-C receive FDA 510(k) clearance?

Aggeris™-C received FDA 510(k) clearance on 2022-03-30, under 510(k) number K220182.

Who is the listed applicant for Aggeris™-C?

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

What is the FDA product code for Aggeris™-C?

The FDA product code for Aggeris™-C is KWQ.

Other records listing Clariance as applicant

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Related Devices (Code: KWQ)

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

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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