vatech A9 (Model : PHT-30CSS)
K-Number: K203797 · 2021-01-25
ApplicantVATECH Co., Ltd.
Decision Date2021-01-25
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
vatech A9 (Model : PHT-30CSS) is a medical device manufactured by VATECH Co., Ltd.. It received FDA 510(k) clearance on 2021-01-25 under approval number K203797. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the vatech A9 (Model : PHT-30CSS)?
vatech A9 (Model : PHT-30CSS) is a medical device that received FDA 510(k) clearance on 2021-01-25. It is manufactured by VATECH Co., Ltd.. The 510(k) number is K203797.
When was vatech A9 (Model : PHT-30CSS) approved by the FDA?
vatech A9 (Model : PHT-30CSS) received FDA 510(k) clearance on 2021-01-25, under approval number K203797.
What company makes vatech A9 (Model : PHT-30CSS)?
vatech A9 (Model : PHT-30CSS) is manufactured by VATECH Co., Ltd..
What is the FDA product code for vatech A9 (Model : PHT-30CSS)?
The FDA product code for vatech A9 (Model : PHT-30CSS) is OAS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.