Aquila 320 D / Aquila 320 S
FDA 510(k) K201340 · Vmi Tecnologias Ltda
510(k) numberK201340
Submission
- Device name
- Aquila 320 D / Aquila 320 S
- Applicant
- Vmi Tecnologias Ltda
Aparecido De Oliveira, Lagoa Santa, BR - Received
- May 20, 2020
- Decision date
- June 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Aquila 320 D / Aquila 320 S cleared by the FDA?
Aquila 320 D / Aquila 320 S (K201340) received a 510(k) decision of Substantially Equivalent on June 19, 2020, 30 days after the submission was received.
What is the product code of K201340?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.