BladderScan Prime PLUS System
K-Number: K172356 · 2017-09-15
ApplicantVerathon Incorporated
Decision Date2017-09-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BladderScan Prime PLUS System is a medical device manufactured by Verathon Incorporated. It received FDA 510(k) clearance on 2017-09-15 under approval number K172356. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BladderScan Prime PLUS System?
BladderScan Prime PLUS System is a medical device that received FDA 510(k) clearance on 2017-09-15. It is manufactured by Verathon Incorporated. The 510(k) number is K172356.
When was BladderScan Prime PLUS System approved by the FDA?
BladderScan Prime PLUS System received FDA 510(k) clearance on 2017-09-15, under approval number K172356.
What company makes BladderScan Prime PLUS System?
BladderScan Prime PLUS System is manufactured by Verathon Incorporated.
What is the FDA product code for BladderScan Prime PLUS System?
The FDA product code for BladderScan Prime PLUS System is IYO.
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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.