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FDA 510(k)

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

K-Number: K193155 · 2020-11-25

ApplicantNipro Renal Solutions USA, Corp.
Decision Date2020-11-25
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is a medical device manufactured by Nipro Renal Solutions USA, Corp.. It received FDA 510(k) clearance on 2020-11-25 under approval number K193155. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Nipro Renal Solutions USA, Corp.. The 510(k) number is K193155.

When was Nipro Dry Complete Dry Acid Concentrate for Hemodialysis approved by the FDA?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis received FDA 510(k) clearance on 2020-11-25, under approval number K193155.

What company makes Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is manufactured by Nipro Renal Solutions USA, Corp..

What is the FDA product code for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis?

The FDA product code for Nipro Dry Complete Dry Acid Concentrate for Hemodialysis is KPO.

Other Devices by Nipro Renal Solutions USA, Corp.

K223431Citric Complete Liquid Citric Acid Concentrate

Related Devices (Code: KPO)

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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.

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