Sensus TPS Workstation
K-Number: K182665 · 2019-02-21
ApplicantSensus Healthcare, Inc.
Decision Date2019-02-21
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sensus TPS Workstation is a medical device manufactured by Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2019-02-21 under approval number K182665. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sensus TPS Workstation?
Sensus TPS Workstation is a medical device that received FDA 510(k) clearance on 2019-02-21. It is manufactured by Sensus Healthcare, Inc.. The 510(k) number is K182665.
When was Sensus TPS Workstation approved by the FDA?
Sensus TPS Workstation received FDA 510(k) clearance on 2019-02-21, under approval number K182665.
What company makes Sensus TPS Workstation?
Sensus TPS Workstation is manufactured by Sensus Healthcare, Inc..
What is the FDA product code for Sensus TPS Workstation?
The FDA product code for Sensus TPS Workstation is MUJ.
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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.