Sofacia System
K-Number: K191421 · 2019-09-09
ApplicantSofwave Medical, Ltd.
Decision Date2019-09-09
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Sofacia System is a medical device manufactured by Sofwave Medical, Ltd.. It received FDA 510(k) clearance on 2019-09-09 under approval number K191421. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sofacia System?
Sofacia System is a medical device that received FDA 510(k) clearance on 2019-09-09. It is manufactured by Sofwave Medical, Ltd.. The 510(k) number is K191421.
When was Sofacia System approved by the FDA?
Sofacia System received FDA 510(k) clearance on 2019-09-09, under approval number K191421.
What company makes Sofacia System?
Sofacia System is manufactured by Sofwave Medical, Ltd..
What is the FDA product code for Sofacia System?
The FDA product code for Sofacia System is OHV.
Other Devices by Sofwave Medical, Ltd.
Related Devices (Code: OHV)
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.