S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
K-Number: K201059 · 2020-07-30
ApplicantSonoscape Medical Corp.
Decision Date2020-07-30
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System is a medical device manufactured by Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2020-07-30 under approval number K201059. 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 S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System?
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Sonoscape Medical Corp.. The 510(k) number is K201059.
When was S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System approved by the FDA?
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2020-07-30, under approval number K201059.
What company makes S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System?
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System is manufactured by Sonoscape Medical Corp..
What is the FDA product code for S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System?
The FDA product code for S60 Elite Series/S70 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.