VALORY— 510(k) K213469

Substantially Equivalent

Agfa N.V.

FDA 510(k) clearance K213469 for VALORY, Substantially Equivalent on 2021-11-18. Applicant: Agfa N.V.. Device class: 2.

Clearance details

Applicant: Agfa N.V.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2021-10-28
Decision date: 2021-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mortsel, BE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.