DVAS (DVAS-M, DVAS-W)
K-Number: K232085 · 2023-12-08
ApplicantGenoray Co., Ltd.
Decision Date2023-12-08
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DVAS (DVAS-M, DVAS-W) is a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2023-12-08 under approval number K232085. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DVAS (DVAS-M, DVAS-W)?
DVAS (DVAS-M, DVAS-W) is a medical device that received FDA 510(k) clearance on 2023-12-08. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K232085.
When was DVAS (DVAS-M, DVAS-W) approved by the FDA?
DVAS (DVAS-M, DVAS-W) received FDA 510(k) clearance on 2023-12-08, under approval number K232085.
What company makes DVAS (DVAS-M, DVAS-W)?
DVAS (DVAS-M, DVAS-W) is manufactured by Genoray Co., Ltd..
What is the FDA product code for DVAS (DVAS-M, DVAS-W)?
The FDA product code for DVAS (DVAS-M, DVAS-W) is EHD.
Other Devices by Genoray Co., Ltd.
Related Devices (Code: EHD)
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.