6200 Ultrasound System and 6250 Ultrasound System
K-Number: K153277 · 2016-05-04
ApplicantEsaote, S.p.A.
Decision Date2016-05-04
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
6200 Ultrasound System and 6250 Ultrasound System is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-05-04 under approval number K153277. 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 6200 Ultrasound System and 6250 Ultrasound System?
6200 Ultrasound System and 6250 Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-05-04. It is manufactured by Esaote, S.p.A.. The 510(k) number is K153277.
When was 6200 Ultrasound System and 6250 Ultrasound System approved by the FDA?
6200 Ultrasound System and 6250 Ultrasound System received FDA 510(k) clearance on 2016-05-04, under approval number K153277.
What company makes 6200 Ultrasound System and 6250 Ultrasound System?
6200 Ultrasound System and 6250 Ultrasound System is manufactured by Esaote, S.p.A..
What is the FDA product code for 6200 Ultrasound System and 6250 Ultrasound System?
The FDA product code for 6200 Ultrasound System and 6250 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.