V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K-Number: K223387 · 2023-02-13
ApplicantSamsung Medison Co., Ltd.
Decision Date2023-02-13
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System is a medical device manufactured by Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2023-02-13 under approval number K223387. 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 V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System?
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-02-13. It is manufactured by Samsung Medison Co., Ltd.. The 510(k) number is K223387.
When was V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System approved by the FDA?
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System received FDA 510(k) clearance on 2023-02-13, under approval number K223387.
What company makes V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System?
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd..
What is the FDA product code for V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System?
The FDA product code for V8 Diagnostic Ultrasound System, V7 Diagnostic 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.