Surdial DX Hemodialysis System
K-Number: K182940 · 2019-07-19
ApplicantNipro Medical Corporation
Decision Date2019-07-19
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Surdial DX Hemodialysis System is a medical device manufactured by Nipro Medical Corporation. It received FDA 510(k) clearance on 2019-07-19 under approval number K182940. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Surdial DX Hemodialysis System?
Surdial DX Hemodialysis System is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by Nipro Medical Corporation. The 510(k) number is K182940.
When was Surdial DX Hemodialysis System approved by the FDA?
Surdial DX Hemodialysis System received FDA 510(k) clearance on 2019-07-19, under approval number K182940.
What company makes Surdial DX Hemodialysis System?
Surdial DX Hemodialysis System is manufactured by Nipro Medical Corporation.
What is the FDA product code for Surdial DX Hemodialysis System?
The FDA product code for Surdial DX Hemodialysis System is KDI.
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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.