FDA · official record K203797Substantially Equivalent

vatech A9 (Model : PHT-30CSS)

Name: vatech A9 (Model : PHT-30CSS) — FDA K203797
Creator: VATECH Co., Ltd.
Keywords: vatech A9 (Model : PHT-30CSS), vatech A9 (Model : PHT-30CSS), K203797, OAS, FDA

United StatesOASVATECH Co., Ltd.

Verified

Official record identity

FDA application number: K203797
Decision date: January 25, 2021
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: VATECH Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2020-12-28
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.