PrevisEA Device
K-Number: K211068 · 2021-08-04
ApplicantEntac Medical, Inc.
Decision Date2021-08-04
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PrevisEA Device is a medical device manufactured by Entac Medical, Inc.. It received FDA 510(k) clearance on 2021-08-04 under approval number K211068. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PrevisEA Device?
PrevisEA Device is a medical device that received FDA 510(k) clearance on 2021-08-04. It is manufactured by Entac Medical, Inc.. The 510(k) number is K211068.
When was PrevisEA Device approved by the FDA?
PrevisEA Device received FDA 510(k) clearance on 2021-08-04, under approval number K211068.
What company makes PrevisEA Device?
PrevisEA Device is manufactured by Entac Medical, Inc..
What is the FDA product code for PrevisEA Device?
The FDA product code for PrevisEA Device is DQD.
Other Devices by Entac Medical, Inc.
Related Devices (Code: DQD)
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.