Isopure Dry Acid Dissolution System
K-Number: K191093 · 2020-01-22
ApplicantIsopure, Corp.
Decision Date2020-01-22
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Isopure Dry Acid Dissolution System is a medical device manufactured by Isopure, Corp.. It received FDA 510(k) clearance on 2020-01-22 under approval number K191093. 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 Isopure Dry Acid Dissolution System?
Isopure Dry Acid Dissolution System is a medical device that received FDA 510(k) clearance on 2020-01-22. It is manufactured by Isopure, Corp.. The 510(k) number is K191093.
When was Isopure Dry Acid Dissolution System approved by the FDA?
Isopure Dry Acid Dissolution System received FDA 510(k) clearance on 2020-01-22, under approval number K191093.
What company makes Isopure Dry Acid Dissolution System?
Isopure Dry Acid Dissolution System is manufactured by Isopure, Corp..
What is the FDA product code for Isopure Dry Acid Dissolution System?
The FDA product code for Isopure Dry Acid Dissolution System is 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.