P20 Elite Series Digital Color Doppler Ultrasound System
K-Number: K221140 · 2022-09-13
ApplicantSonoscape Medical Corp.
Decision Date2022-09-13
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
P20 Elite Series Digital Color Doppler Ultrasound System is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2022-09-13 under approval number K221140. 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 P20 Elite Series Digital Color Doppler Ultrasound System?
P20 Elite Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K221140.
When was P20 Elite Series Digital Color Doppler Ultrasound System approved by the FDA?
P20 Elite Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2022-09-13, under approval number K221140.
What company makes P20 Elite Series Digital Color Doppler Ultrasound System?
P20 Elite Series Digital Color Doppler Ultrasound System is manufactured by Sonoscape Medical Corp..
What is the FDA product code for P20 Elite Series Digital Color Doppler Ultrasound System?
The FDA product code for P20 Elite Series Digital Color Doppler 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.