EzRay M (Model: VMX-P300)
FDA 510(k) K203667 · VATECH Co., Ltd.
510(k) numberK203667
Submission
- Device name
- EzRay M (Model: VMX-P300)
- Applicant
- VATECH Co., Ltd.
Hwaseong-Si, KR - Received
- December 16, 2020
- Decision date
- February 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K223058 | EzRay Air 2 Wall (Model: VEX-S350W)EHD · Special | 10/26/2022SE |
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| K210329 | Green X 18(Model : PHT-75CHS)OAS · Special | 02/18/2021SE |
| K203797 | vatech A9 (Model : PHT-30CSS)OAS · Special | 01/25/2021SE |
| K201627 | Dental Computed Tomography X-Ray System, Green XOAS · Traditional | 10/27/2020SE |
Questions and answers
When was EzRay M (Model: VMX-P300) cleared by the FDA?
EzRay M (Model: VMX-P300) (K203667) received a 510(k) decision of Substantially Equivalent on February 2, 2021, 48 days after the submission was received.
What is the product code of K203667?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.