Terason uSmart 3200T Plus Ultrasound System
K-Number: K201633 · 2020-07-02
ApplicantTeratech Corporation
Decision Date2020-07-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Terason uSmart 3200T Plus Ultrasound System is a medical device manufactured by Teratech Corporation. It received FDA 510(k) clearance on 2020-07-02 under approval number K201633. 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 uSmart 3200T Plus Ultrasound System?
Terason uSmart 3200T Plus Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-07-02. It is manufactured by Teratech Corporation. The 510(k) number is K201633.
When was Terason uSmart 3200T Plus Ultrasound System approved by the FDA?
Terason uSmart 3200T Plus Ultrasound System received FDA 510(k) clearance on 2020-07-02, under approval number K201633.
What company makes Terason uSmart 3200T Plus Ultrasound System?
Terason uSmart 3200T Plus Ultrasound System is manufactured by Teratech Corporation.
What is the FDA product code for Terason uSmart 3200T Plus Ultrasound System?
The FDA product code for Terason uSmart 3200T Plus 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.