UniPulse
K-Number: K182905 · 2018-12-14
ApplicantSeaward Group
Decision Date2018-12-14
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
UniPulse is a medical device manufactured by Seaward Group. It received FDA 510(k) clearance on 2018-12-14 under approval number K182905. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UniPulse?
UniPulse is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Seaward Group. The 510(k) number is K182905.
When was UniPulse approved by the FDA?
UniPulse received FDA 510(k) clearance on 2018-12-14, under approval number K182905.
What company makes UniPulse?
UniPulse is manufactured by Seaward Group.
What is the FDA product code for UniPulse?
The FDA product code for UniPulse is DRL.
Related Devices (Code: DRL)
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.