510(k) K203667

EzRay M (Model: VMX-P300) by VATECH Co., Ltd. — Product Code IZL

K203667 is an FDA 510(k) premarket notification submitted by VATECH Co., Ltd. for the device "EzRay M (Model: VMX-P300)". The FDA issued a decision of Substantially Equivalent on February 2, 2021. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. VATECH Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2021
Date Received
December 16, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type