Sonosite PX Ultrasound System
K-Number: K213763 · 2021-12-27
ApplicantFUJIFILM Sonosite, Inc.
Decision Date2021-12-27
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sonosite PX Ultrasound System is a medical device manufactured by FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2021-12-27 under approval number K213763. 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 Sonosite PX Ultrasound System?
Sonosite PX Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-12-27. It is manufactured by FUJIFILM Sonosite, Inc.. The 510(k) number is K213763.
When was Sonosite PX Ultrasound System approved by the FDA?
Sonosite PX Ultrasound System received FDA 510(k) clearance on 2021-12-27, under approval number K213763.
What company makes Sonosite PX Ultrasound System?
Sonosite PX Ultrasound System is manufactured by FUJIFILM Sonosite, Inc..
What is the FDA product code for Sonosite PX Ultrasound System?
The FDA product code for Sonosite PX 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.