HydroCision TenJet Device
K-Number: K190804 · 2019-06-05
ApplicantHydrocision, Inc.
Decision Date2019-06-05
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
HydroCision TenJet Device is a medical device manufactured by Hydrocision, Inc.. It received FDA 510(k) clearance on 2019-06-05 under approval number K190804. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HydroCision TenJet Device?
HydroCision TenJet Device is a medical device that received FDA 510(k) clearance on 2019-06-05. It is manufactured by Hydrocision, Inc.. The 510(k) number is K190804.
When was HydroCision TenJet Device approved by the FDA?
HydroCision TenJet Device received FDA 510(k) clearance on 2019-06-05, under approval number K190804.
What company makes HydroCision TenJet Device?
HydroCision TenJet Device is manufactured by Hydrocision, Inc..
What is the FDA product code for HydroCision TenJet Device?
The FDA product code for HydroCision TenJet Device is HRX.
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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.