FDA 510(k)

VALORY

K-Number: K213469 · 2021-11-18

Decision Date2021-11-18

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VALORY is the device name listed in this FDA 510(k) record. The listed applicant is Agfa N.V.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213469. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALORY?

VALORY is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Agfa N.V.. The 510(k) number is K213469.

When did VALORY receive FDA 510(k) clearance?

VALORY received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213469.

Who is the listed applicant for VALORY?

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

What is the FDA product code for VALORY?

The FDA product code for VALORY is MQB.

Other records listing Agfa N.V. 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: MQB)

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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.