Terason uSmart3200T Ultrasound System
K-Number: K193510 · 2020-01-28
ApplicantTeratech Corporation
Decision Date2020-01-28
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Terason uSmart3200T Ultrasound System is a medical device manufactured by Teratech Corporation. It received FDA 510(k) clearance on 2020-01-28 under approval number K193510. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Terason uSmart3200T Ultrasound System?
Terason uSmart3200T Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-01-28. It is manufactured by Teratech Corporation. The 510(k) number is K193510.
When was Terason uSmart3200T Ultrasound System approved by the FDA?
Terason uSmart3200T Ultrasound System received FDA 510(k) clearance on 2020-01-28, under approval number K193510.
What company makes Terason uSmart3200T Ultrasound System?
Terason uSmart3200T Ultrasound System is manufactured by Teratech Corporation.
What is the FDA product code for Terason uSmart3200T Ultrasound System?
The FDA product code for Terason uSmart3200T Ultrasound System is IYN.
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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.