EzRay M18 (Model: VMX-P400)
FDA 510(k) K213462 · VATECH Co., Ltd.
510(k) numberK213462
Submission
- Device name
- EzRay M18 (Model: VMX-P400)
- Applicant
- VATECH Co., Ltd.
Hwaseong-Si, KR - Received
- October 27, 2021
- Decision date
- February 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was EzRay M18 (Model: VMX-P400) cleared by the FDA?
EzRay M18 (Model: VMX-P400) (K213462) received a 510(k) decision of Substantially Equivalent on February 11, 2022, 107 days after the submission was received.
What is the product code of K213462?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.