The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for System, X-ray, Extra Oral Source, Digital, Pax-i Plus, Pax-i Insight.
Device ID | K170731 |
510k Number | K170731 |
Device Name: | System, X-Ray, Extra Oral Source, Digital, PaX-i Plus, PaX-i Insight |
Classification | System, X-ray, Extraoral Source, Digital |
Applicant | Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si, KR 445-170 |
Contact | Daniel Kim |
Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
Product Code | MUH |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-10 |
Decision Date | 2017-04-04 |
Summary: | summary |